INDUSTRY PROGRAM GUIDE - Amazon Web Servicesamerican-safe-access.s3.amazonaws.com/documents/Talana/Patient... · Industry Program Guide ... Manufacturing, Packaging, ... while teaching

Patient Focused Certification

INDUSTRYPROGRAM GUIDE

1806 Vernon Street NW, Washington, D.C. 20009AmericansForSafeAccess.orgPhone: (202) 857-4272Fax: (202) 618-6977

A Project of Americans for Safe Access Foundation

AmericansForSafeAccess.org PatientFocusedCertification.org

Industry Program Guide

I. Introduction ............................................................................................................. 1

II. PFC Benefits and Services....................................................................................... 2

III. Developing and Adopting Industry Standards: AHPA and AHP ...................... 5

IV. Industry Trainings .................................................................................................... 7

V. Types of Certification Offered by PFC .................................................................. 9

VI. Certification Process ..............................................................................................12

VII. Ongoing Review and Compliance Process .........................................................15

VIII. Program Oversight.................................................................................................15

IX. PFC Auditor Qualifications ...................................................................................17

X. Fees and Discounts.................................................................................................16

XI. About ASA AHPA, and AHP ................................................................................ 17

XII. Frequently Asked Questions.................................................................................18

XIII. PFC Application` .....................................................................................................20

XIV. PFC Sample Audit Forms

1. Cultivation and Processing .............................................................................. 23

2. Manufacturing, Packaging, Labeling, and Holding..................................... 39

3. Laboratory Analysis .......................................................................................... 94

4. Distribution.......................................................................................................115

AmericansForSafeAccess.org 1

Introduction

Welcome to the Patient Focused Certification (PFC) Program!

Americans for Safe Access Foundation (ASA) has created the Patient Focused Certification (PFC) Program toaddress issues of quality control and product safety in the cannabis industry to ensure patients (consumers) andtheir healthcare providers can rely on high-quality medical cannabis products and services. ASA has been advo-cating for safe and legal access to cannabis for therapeutic use and research on behalf patients for over adecade. Founded in 2002, ASA developed a vision for safe access that includes a legal and regulatory frame-work that has shaped the medical cannabis industry we see today.

The PFC Program has established guidelines that provide a system of processes, procedures, and documentationto ensure that Cannabis products (hemp, medical cannabis, and cannabis-derived products intended for humanconsumption) have the strength, composition, purity, and identity they claim to constitute or possess. PFC helpscompanies that are cultivating, manufacturing, and distributing these products achieve a commitment to quali-ty and product safety. PFC represents the consensus of the world’s leading experts on cannabis, hemp andbotanical product regulations.

The PFC program addresses quality control and product safety through:

1. Developing and Adopting Industry Standards

2. Industry Training

3. Certification Program

To date, we have:

��• Worked with American Herbal Pharmacopoeia (AHP) to release a Cannabis Monograph, which nowserves as a guide for identifying the quality, purity, and potency of the cannabis plant internationally;

�• Collaborated with the American Herbal Products Association (AHPA) to create the AHPA CannabisCommittee which has developed industry standards in the form of Recommendations for Regulators forDistribution, Cultivation, Analytics, and Manufacturing, Packaging and Labeling;

�• Worked with regulators to get AHP and AHPA cannabis standards adopted in over a dozen states and;

�• Partnered with American Chemical Society (ACS) divisions of Small Chemical Business(SCHB), Agricultureand Food (AGFD), and Chemical Health & Safety(CH&S) to create a Cannabis Chemistry committee toprovide education and training that addresses the needs of laboratories, chemists, and service/equipmentproviders

Our experienced staff have trained thousands in the medical cannabis industry over the last decade. The PFCtraining program prepares employees to understand state and local regulations and to meet required safetyand operational protocols, while teaching them the basics of cannabis as medicine and common therapeuticuses of cannabis. PFC training is currently licensed by the Department of Public Health in the District ofColumbia as a mandatory training for all staff working in the DC medical cannabis program.

PFC offers third-party certification and support services to companies cultivating, manufacturing, analyzing ordistributing medical cannabis products and is the nation’s only certification program based upon the AHPA andAHP standards. All PFC companies are required to adhere to these rigid quality standards. Certification includescompliance inspections, ongoing monitoring, regulatory updates, staff training and an independent complaintprocess for consumers.

PFC certified laboratories have each demonstrated that their equipment and instruments are calibrated andmaintained properly. Laboratories must also show that they have implemented operating protocols that arefollowed in accordance with the AHP Monograph and AHPA guidelines, establishing the first standardizedtesting of medical cannabis and medical cannabis products. Through standardized testing, patients and theirmedical practitioners can now have confidence that the products utilized not only comply with PFC’s highquality and safety standards, but are also properly labeled and standardized to ensure consistency of quality

2 PatientFocusedCertification.org

and effectiveness.

PFC certified companies are awarded the distinctive PFC mark to be displayed on promotional materials, prod-uct labeling and packaging to help distinguish products for consumers. PFC is similar to other nationally recog-nized certification programs including United States Pharmacopoeia (USP), Good Housekeeping, NSF, andInternational Organization for Standardization (ISO). PFC certification is currently offered as a voluntary certifi-cation program in all medical cannabis states for cultivators, manufacturers, dispensaries, and laboratories.

PFC Certification Highlights:

1. offers cannabis businesses a third-party auditing option that ensures compliance with standards requiredunder regulation and best practices;

2. provides your company visibility in all PFC advertising and marketing programs to patients, caregivers,and health care providers;

3. provides a mark that lets consumers, policy makers, regulators, health inspectors, community membersand health care providers know that companies are meeting compliance and product safety standardrequirements;

4. monitors violations of regulations;

5. provides trainings that include: Legal Issues, Robbery Preparedness, Patient Education, Good NeighborPolicies, Safe Handling Protocols, Working with Patient Populations, Understanding Test Results andDelivery Systems, Adherence to Local Laws and Regulations, and Adherence to AHPA and AHP standards;

6. provides companies with educational materials for patients, caregivers, healthcare providers and regula-tors that describe the certification program;

7. provides a third-party process to evaluate complaints, allowing you to identify, focus on and resolvelegitimate quality and service issues;

8. funds activities that benefit the medical cannabis industry, including education, legal services andresearch;

9. verifies through independent auditors that state and local rules, as well as AHPA and AHP standards, arefollowed by companies, ensuring patient safety and product quality, purity, and reliability;

10. offers third-party certification that can help reduce company liability and oversight burden;

11. provides companies and, if required, regulators with annual Audit Reporting;

12. assists your company with regulatory acceptance by verifying the reliability, consistency, and accuracy ofyour processes;

13. is overseen by a Peer Review Board that has over 300 years of collective expertise in USDA food andproduct safety protocols; federal regulatory development; medical cannabis research, pharmacology, bio-chemistry, and industry practices.

II. PFC Benefits and Services

BENEFITS

Government Relations: PFC works at the local and state level to increase awareness of the AHPA standards andthe AHP Cannabis Monograph with relevant agencies. PFC and AHPA work directly with legislators, regulatorsand industry trade groups to encourage the adoption of AHPA’s Recommenda-tions to Regulators and stan-dards outlined in the AHP Cannabis Monograph. As such, regulators in the states of Alaska, Florida, New York,Illinois, Maryland, Nevada, Washington, Oregon, Massachusetts, Minnesota, Hawaii, and Colorado have adopt-ed portions of the AHPA’s Recommenda-tions and/or the AHP Cannabis Monograph.

As the regulatory framework for medical cannabis businesses continues to develop throughout the US, demon-strating adherence to national best-practice standards can help businesses avoid being subjected to the devel-opment of onerous state and local regulations that may challenge the ability of small businesses to be


successful. Throughout history, big business, with the support of government, has used unnecessarily narrow orstringent regulations to monopolize marketplaces. Certifying your business with PFC shows regulators and law-makers that your business has high standards of operation in accordance with other botanical products, dis-couraging the development of overly restrictive regulations.

Both ASA and AHPA are dedicated to the adoption of mandatory standards for the medical cannabis industrynationally. Your participation in the PFC Program helps to ensure that our outreach to your specific regulatorsgives your company an advantage.

Be prepared for regulatory inspections: In today’s regulated marketplace, failure to meet regulatory com-pliance can result in the denial of licensure for an applicant. Or, in the case of an established company canresult in costly fines, the recall and/or confiscation of products, and suspension or termination of your compa-ny’s license. As a participant in the PFC program, your company can rest assured that PFC’s inspection auditorswill identify any and all compliance issues that could jeopardize your company’s ability to maintain compliancewith local and state regulations. As localities and state regulators adjust and update regulations, PFC staff willensure that your company is aware of all upcoming regulatory changes.

Reduce company liability: Prior to the adoption of product safety guidelines in the herbal, botanical, andnutraceutical industries product liability lawsuits continually challenged the stability, growth, and future ofthese companies. As public concern in the US mounted over the increasing number of product liability lawsuitslarger agencies such as the FDA entered into the conversation about regulations and pressures rose to restrictherbal, botanical, and nutraceutical products from public availability. However, through the voluntary adop-tion of rigorous product safety guidelines, the herbal, botanical and nutraceutical industry was able to ease theconcerns of both the public and regulatory agencies allowing the industry to stabilize and avoid overly onerousFDA regulations.

Today, the medical cannabis and adult use industry find themselves in a very similar situation. As medicalcannabis and adult use laws have been implemented throughout the US, product safety has been an after-thought in many of these laws and rule making processes. By working with PFC to adopt nationally recognizedproduct safety standards, you directly reduce your company’s service and product liability. Through proper lotand batch number tracking, health and hygiene protocols, standardized testing, proper labeling, as well asadverse event reporting and recall strategies cannabis businesses who wear the PFC seal of approval raise thebar of product safety to that of the herbal, botanical, and nutraceutical industry in the US.

PFC certification helps your company identify, develop and address product safety protocols before a productsafety liability issue can arise. Engaging in the PFC program costs the average company less than 1% of theirannual revenue whereas product liability lawsuits often cost companies hundreds of thousands of dollars. LetPFC help your company develop a solid foundation of product safety and avoid costly product liability lawsuitsthat often irreparably damage businesses or close them all together.

Instill confidence in consumers and health care providers: The PFC seal displayed by cannabis businessesand on cannabis/hemp products provides medical practitioners, patients, and regulators with peace of mindthat your company is adhering to regulatory guidelines. The seal also shows that your company is committed tothe purity and identity of products being sold, has implemented lot and batch number tracking protocolsincluding an operations product recall plan, and has implemented standardized methods for the cultivation,manufacturing, distribution, and lab testing of those products.

Additionally our outreach programs educate patients, their caregivers, and medical professionals to look forPFC certified products so that they can choose their medicine with confidence, knowing that it was produced ina manner that provides consistent results and protects consumer safety. PFC’s advertising and marketing promi-nently features our certified companies and includes both traditional industry publications and unique chan-nels, such as Complementary and Alternative Medicine outlets.

Have confidence in company compliance: As medical cannabis, adult use, and hemp businesses haveemerged in the legal marketplace , state and local lawmakers have created a patchwork of laws and regula-tions. Almost all companies entering into the PFC program will find that some form of corrective action is nec-essary to achieve and maintain certification. Let PFC help your company achieve excellence in compliance, Best


Business Practices, quality of care, and product safety.

Due to the ever-changing and expanding nature of medical cannabis regulations and medical cannabis industryinnovations, PFC recognizes the need to continually review and adopt new standards and guidelines thatreflect regulatory changes. For this reason the PFC Program has been developed as a continually evolving pro-gram overseen by a Peer Review Board which along with AHPA and AHP act to oversee the ongoing update ofPFC program standards. Depending on the extent of standard updates approved by the PFC Peer Review Board,a PFC auditor may be assigned to the affected certified companies in order to verify that all necessary compli-ance updates have taken place. Additional staff training may also be required. The addition of programrequirements, determination of corrective actions, and need for additional trainings, are all determined by thePFC Peer Review Board.

Complaint hotline, investigation and resolution: PFC operates an independent complaint hotline that pro-vides patients, consumers, and caregivers the means to report a concern, complaint, or adverse event relatingto a service or product. If a verified third-party complaint is recorded and it is determined to require an investi-gation or a large number of complaints are lodged against a specific certified service or product, a review auditmay be necessary. PFC will evaluate and respond to all third-party complaints verifying the legitimacy andseverity of the complaint, and when necessary, require immediate corrective action. Certified companies arerequired to respond to complaint inquiries within five (5) business days of notification by an assigned PFC audi-tor or staff person.

When filing a complaint, a Complaint Investigation Request provided by PFC and available online, must becompleted and signed by the complaining party. Complaints will be sent directly to the Program Director, whowill track all complaints and investigations. PFC will acknowledge receipt of the complaint, promptly investigateand validate the complaint, and take appropriate actions. PFC shall ensure the proper corrective actions havebeen implemented and notify the complainant of such actions. The certified company will be advised of thecomplaint at the appropriate time during the investigation. PFC shall determine, together with the certifiedcompany and complainant (and regulators where necessary), if the complaint and resolution should be madepublic.

When a complaint is made by a company, whether PFC certified or not, the complainant agrees to bear thecost of an investigation if the complaint is not verified. If the complaint is substantiated, the certified companyshall be responsible for all costs of the investigation. Regulatory authorities, individual consumers, and licensedhealth care providers are exempt from bearing the costs of any investigation costs. PFC shall not identify thecomplainant unless required to do so by law. If a complainant does not sign a Complaint Investigation Request,PFC will consider it an informal complaint and will investigate as needed but has no obligation to investigate orrespond.

Services: Patient Focused Certification offers a variety of services designed to calibrate your business for excel-lence regardless of whether your company is just entering into the marketplace or is already an establishedprovider.

PFC Advisory Services: Not sure if your company is ready to engage in the PFC program? Starting a newbusiness and need guidance on local and state compliance or Best Business Practices? Or, maybe you have anin-house production lab that doesn’t qualify for certification but your company could benefit from bringing itup to PFC standards? The Patient Focused Certification staff can help your company answer these questionsthrough the PFC Advisory Services Program. The PFC Advisory Program gives your company access to some ofthe industry’s best technical experts, delivering consistent, personalized service with the highest levels ofintegrity. To engage in PFC’s Advisory Services, simply fill out an application and check the Advisory Servicebox. Within 5 business days a PFC staff person will contact your company to discuss the breadth of servicesdesired and assign the appropriate staff and/or auditor(s) to assist your company. All PFC Advisory Services arebilled at a rate of $150 per hour plus travel expenses.

Pre-licensing Certification: Companies interested in the PFC program but not yet licensed can engage in thePFC program and begin the audit process prior to license approval by providing PFC with a 50% deposit. In thiscase, the company must be able to show verification that all staff, as identified on the application, have success-fully completed the PFC Core Cannabis Training and that the company has successfully completed a document


audit of all proposed SOP’s and Employee Manuals by an assigned PFC auditor. As with other document auditsconducted for PFC, the assigned PFC auditor will create a detailed audit report for the company outlining anycorrective actions necessary for the SOP’s to meet the standards of the PFC program as well as local and stateregulatory requirements. All corrective actions must be successfully implemented prior to receiving PFCapproval from the assigned auditor. PFC will then provide the company with a letter of engagement verifyingthat the provided documents are of adequate content to show that the company has implementable proce-dures ensuring compliance with local and state laws, and applicable PFC standards. Upon approval of statelicensure, your company is encouraged to complete the PFC required trainings. All companies engaged in pre-licensing certification are required to complete the certification process within 90 days of opening the companyfor operation.

Industry Certification: Medical cannabis, adult use cannabis and hemp product companies operating withinthe legal parameters of local and state regulations are encouraged to apply for the PFC certification . OncePFC has received the required 50% deposit, PFC staff will assign an independent auditor to your company andschedule the document and physical audits. PFC staff will also request a full employee list from your companyand assist your company in enrolling in the required PFC training courses. Upon the successful completion ofthe pre-certification audit process, subsequent corrective actions, and required staff trainings PFC staff willissue your company an official certification packet, including directions for the proper branding and use ofthe PFC seal.

Industry Training: PFC’s required staff training program is designed to meet the requirements of statemandated training programs, provide your staff with continuing educational opportunities, and can helpyour company reduce the cost of developing, implementing and operating in-house medical cannabis train-ing programs.

III. Developing and Adopting Industry Standards: AHPA and AHP

Seed to consumption national quality standards now exist for the medical cannabis industry thanks to the 2011collaboration of ASA, the American Herbal Products Association (AHPA), and the American HerbalPharmacopoeia (AHP). This unique collaboration combines the expertise of ASA, the nation’s largest medicalcannabis patient advocacy organization; AHPA, the principal U.S. trade association and voice of the herbalproducts industry since 1982; and the AHP, an organization that has developed qualitative and therapeuticmonographs on Western herbs since 1994. The result is that patients, healthcare providers, lawmakers, regula-tors, and medical cannabis businesses now have the tools they need to ensure reliable, high-quality hemp,medical cannabis, and medical cannabis products.

Founded in 1982, AHPA is the oldest non-profit organization specializing inservice to the herbal industry. All of AHPA’s activities are focused on its mis-sion, to promote the responsible commerce of herbal products. These activi-ties are undertaken to maintain and improve market opportunities for

companies that sell herbs, herbal and botanical products, and other health-related products, including foods,beverages, dietary supplements, and personal care products, while also ensuring that consumers continue toenjoy informed access to a wide choice of goods. In 2010 AHPA established a Cannabis Committee tasked withthe development of national Recommendations to Regulators that address sensible regulatory practices forhemp, cannabis, and cannabis-derived products. As such, the AHPA’s Cannabis Committee developed a series ofRecommendations to Regulators, or guidelines, in the following four areas:

1. Cultivation and Processing—Intended to establish a basis for oversight of entities that cultivate cannabisin outdoor, greenhouse, and/or indoor facilities, these guidelines address good cultivation practices,pesticide guidance, facility requirements, management of water resources, recordkeeping, product safetyrecall systems, adverse event recording, and information disclosure. These recommendations alsoestablish best practices and safe handling procedures for operations that provide post-harvest processingof cannabis.

2. Manufacturing, Packaging, Labeling and Holding—Intended to establish a basis for oversight of entitiesthat are engaged in the manufacturing of cannabis and cannabis-derived products, these guidelines are


modeled after federally recognized Good Manufacturing Practices (GMPs) for botanical andnutraceutical products. These recommendations ensure that GMP’s are maintained in manufacturingoperations by focusing on personnel, physical condition of the plant and surrounding grounds,manufacturing controls, packaging, holding, and labeling controls, cannabis material acquisition,inventory and recordkeeping, complaints, returns, product safety recalls, and adverse event recording.

3. Distribution—Intended to establish a basis for oversight of entities that provide cannabis and cannabis-derived products directly to compliant individuals through storefront operations, delivery services, direct-from-garden operations, and growing co-op operations, these guidelines focus on personnel, security,product acquisition, record keeping, customer policies, implementable product safety recall systems,adverse event recording, and other matters that can contribute to best practices in the dispensarysetting.

4. Laboratory Analysis—Intended to establish a basis for the oversight of entities performing laboratoryanalysis of cannabis, cannabis-derived products, and hemp products, these guidelines were developed asa complement to existing good laboratory practices and focus on the personnel, security, samplehandling and disposal, data management, personnel safety and hygiene, and reporting activities thatmay be unique to laboratories analyzing cannabis, cannabis-derived products, and hemp samples. Inaddition to the AHPA guidelines, PFC certified laboratories are also required to adhere to the standardspresented in the AHP Cannabis Monograph.

Established in 1995, the American Herbal Pharmacopoeia (AHP) is a non-profit501(c)(3) California- based organization with a mission to promote the respon-sible use of herbal products and herbal medicines. The AHP produces criticallyreviewed documents called monographs that outline the quality control criteria

needed for ensuring the identity, purity, and quality of botanical raw materials.

Each monograph also presents a complete and critical review of the traditional and scientific literature regard-ing the efficacy and safety of herbal medicines and includes information on specific products such as tincturesand extracts. In 2011, the AHP began the development of a Cannabis Monograph and a TherapeuticCompendium for Cannabis. The first edition of the Cannabis Monograph was released in 2013 and provides sci-entifically valid standards for companies engaged in laboratory analysis of cannabis, cannabis-derived products


and hemp products with regards to:

1. Ensuring the identity, quality, purity, and potency of cannabis, cannabis-derived and hemp products;

2. Reporting, analytic equipment calibration and method validation;

3. And, ensuring product safety by identifying safe levels of pesticides, metals, and microbial limits.

PFC works at the local and state level to increase awareness and adoption of the AHPA guidelines and the AHPCannabis Monograph with relevant agencies. PFC and AHPA also works directly with regulators and industrytrade groups to coordinate the further development of cannabis industry standards. ASA is dedicated to theadoption of mandatory standards for the cannabis industry nationally. Quality control and product safety stan-dards based on the AHPA guidlines and the AHP Cannabis Monograph have been adopted in over a dozenstates.

IV. Industry Training

As state medical cannabis laws and regulations continue to evolve, medical cannabis-specific trainings havebecome increasingly mandated. States such as Arizona, Massachusetts, Nevada, Florida, Illinois, Connecticut,Washington, Maryland, Oregon, and the District of Columbia have mandated comprehensive training for allstaff working or volunteering in state-licensed medical cannabis facilities. PFC’s required staff training programis designed to meet the requirements of state mandated training programs and can help your company reducethe cost of developing, implementing and operating in-house medical cannabis training programs.

PFC currently holds the first government-issued educational permit from the District of Columbia to provide therequired staff trainings for the District’s legal medical cannabis providers. Additionally, PFC has been awarded acontract with the State of Maryland to train all compliance inspectors for the State’s medical cannabis program.

As a leader in medical cannabis education since 2002, ASA has distributed millions of copies of educational litera-ture to patients, healthcare professionals, researchers, industry labor, regulators, and concerned communitymembers and has conducted thousands of legal and advocacy trainings nationwide.

The PFC required trainings include the Core Cannabis Training, the National Cannabis Standards training(s) anda State Specific Legal and Compliance training. PFC is constantly developing new course material designed tofulfill the requirements of state mandated trainings, while providing ongoing educational opportunities toenrich and meet the continuing educational needs of your company’s staff. PFC trainings are available onlineor are offered in-person by a PFC Certified Instructor.

1. CORE CANNABIS TRAINING (CCT)

This training provides the foundation for PFC required trainings and is a prerequisite for all additional training.All paid and volunteer staff, working at a PFC company, are required to successfully complete the CCT. The CCTcourses address the following topics:

�• CANNABIS RESEARCH AND CLINICAL DATA: Find out what research is revealing about the therapeuticpotential of cannabis, and learn what types of pain, disorders and diseases this plant potentially relieves.Clinical trials and their importance are also covered. Finally, see what groundwork has been laid forfuture cannabis research.

�• THE ENDOCANNABINOID SYSTEM: This module gives a brief history of opioids and cannabinoids, andexplains how the endocannabinoid system was discovered. The workings of the endocannabinoidsystem. This module will also explore the physiological role of endocannabinoids.

�• CANNABIS 101: Gain a fundamental understanding of the cannabis plant by learning the varieties ofcannabis and their uses, the most common cannabinoids, the effects of cannabis, and the differencebetween psychoactive and non-psychoactive cannabinoids.

�• CANNABIS-BASED MEDICINES: Cannabis-Based Medicines covers the cannabis pharmaceuticals that are


currently available. It also takes a look at cannabis extracts and concentrates and how they might beused. The module concludes with a section on cannabis edibles including a brief discussion about howcannabis might be incorporated into topicals, food and drink.

��• QUALITY OF CARE: Targeted at dispensary workers, this module covers customer service, how to identifyand handle medical emergencies, and patient education. A discussion of the Patient’s Bill of Rightsfinishes the module.

�• KNOW YOUR RIGHTS: This module prepares you for interactions with federal law enforcement (FLE).Know what to do in event of detainment or arrest as well as how to answer questions from FLE. Finally,understand when Miranda warnings apply.

�• ROBBERY PREPAREDNESS: Cannabis businesses, like other businesses, are at risk for being robbed .Know what to do should this happen. In this module, learn what operations should be followed duringa robbery to keep employees safe . Discover what logistical and security preparations should be taken inadvance to decrease the chances of a robbery and what protocols should be in place for staff andcustomers should they bep resent during a robbery.

�• RUNNING A SAFE BUSINESS: Dispensaries, cultivators, and processing centers alike need to takeprecautions to ensure the safety of their product. Learn how to spot contaminants and maintain safeand sanitary conditions. Security considerations will also be discussed. The module concludes with tips onneighborhood and community relations.

2. NATIONAL STANDARDS COURSES

The National Cannabis Standards Training(s) are designed to educate attendees about the particulars of compli-ance specific to the AHPA and AHP guidelines. National Cannabis Standards Trainings are available in fourcannabis industry disciplines. All paid and volunteer staff working at PFC companies are required to successful-ly complete the National Standards Course work in the discipline(s) that the staff person will be working in. Forexample, all staff working in cultivation and/or processing facilities must successfully complete the NationalStandards Course in Cultivation and Processing.

A. CULTIVATION AND PROCESSING: Based on the AHPA Recommendations to Regulators for Cultivationand Processing operations, this training applies to all types of cultivation operations including outdoor,greenhouse, and indoor cultivation facilities. This training is designed to provide learners with the skillsnecessary to implement Good Cultivation Practices including pesticide guidance, facility requirements,water resource management, recordkeeping, product safety recall systems, adverse event reporting, andinformation disclosure. This course also explores best practices and safe handling procedures foroperations that provide post-harvest processing of cannabis.

B. MANUFACTURING, PACKAGING, LABELING AND HOLDING: Designed for individuals engaged in themanufacturing of hemp and cannabis-derived products, this training is designed to provide learners withthe tools necessary to comply with General Manufacturing Practices including general personnelresponsibility and safety, physical condition of the plant and surrounding grounds, manufacturingcontrols including packaging, holding and labeling controls, cannabis material acquisition, inventory andrecordkeeping, fielding and documenting complaint,product returns, product safety recalls, and adverseevent reporting.

C. DISTRIBUTION: This comprehensive training is designed to provide participants with the skills necessaryto implement Best Management Practices relating to the distribution of cannabis, cannabis-derivedproducts, and hemp-derived products directly to compliant individuals through storefront operations,delivery services, direct-from-garden operations, and growing co-op operations. This training includesinformation regarding personnel policies, facility security, product acquisition, record keeping, customerpolicies, implementable product safety recall systems, and adverse event reporting.

D. LABORATORY: Designed for individuals performing laboratory analysis of cannabis, cannabis-derivedproducts, and hemp products, this course has been developed to educate learners on good laboratorypractices and focuses on facility security, sample handling and disposal, data management, personnelsafety and hygiene, and reporting activities that may be unique to laboratories analyzing cannabis,cannabis- derived products, and hemp product samples.


3. STATE SPECIFIC COMPLIANCE TRAINING

Each State-Specific Compliance Training is designed to give medical cannabis staff a comprehensive foundationof knowledge, ensuring they know the compliance expectations of local and State government and regulatoryagencies.

� �• STATE AND LOCAL LAWS: Medical cannabis facilities are often regulated by both State and local laws.During this training, participants will get to know their local and state medical cannabis laws and howthose laws apply to them as medical cannabis facility staff, as well as to the patients they will be serving.

� �• STATE AND LOCAL REGULATIONS: This training provides a broad regulatory overview, necessary tomaintain compliance, in all disciplines of the medical cannabis industry. Because compliance may besubject to both State and local oversight, this training discusses the specifics of both local and Stateregulatory provisions.

ADDITIONAL STATE REQUIREMENTS

As medical cannabis laws continue to evolve, additional trainings above and beyond the PFC required trainingsare sometimes required by law. For this reason, PFC offers a broad array of “enrichment courses” designed toassist medical cannabis businesses in fulfilling all mandatory training requirements. Additionally, whererequired by law, these trainings will cover the specific aspects of the State and local requirements unique to theoperation of that State’smedical cannabis program. These trainings may also be utilized to meet the continuingeducation requirements of PFC companies engaging in recertification and include, but are not limited to, thefollowing PFC course options.

� �• PESTICIDE GUIDANCE AND INTEGRATED PEST MANAGEMENT (IPM): This in-person course isrecommended for all staff who will be working in cultivation and processing facilities. During thiscourse, students are familiarized with key definitions pertaining to pesticides and learn how to properlyread a pesticide label. The course will also explore the importance and function of tolerance thresholds,major chemical families, Restricted Entry Intervals (REI’s), and Personal Protective Equipment (PPE’s) aswell as employee safety and employer responsibilities. The second portion of this course covers the keycomponents to successful IPM.

� �• SUSTAINABILITY, SANITATION, AND RECORD KEEPING FOR CULTIVATION FACILITIES: This course isrecommended for all PFC company staff engaged in cultivation and processing operations . Designed tohelp cultivators reduce their impact on the environment, this course provides tools for reducing thecarbon footprint of cultivation operations as well as the use, recycling and reuse of mediums. In addition,this course discusses appropriate nutrient use, the consequences of mined and imported materials, andthe proper storage of chemicals. Water resource use, storage, and reduction techniques are alsoaddressed in this course as well as the proper tracking of materials used during the cultivation process.

� �• REPRESENTATIVE BATCH and LOT SAMPLING - QA/QC: This course is recommended for of all PFC staffregardless of the discipline(s) they will be employed for. During this course, learners will be providedwith an overview of paradigm shifts and global perspective relating to Quality Assurance (QA) andQuality Control (QC). Details on developing and implementing QA/QC systems will be discussedincluding method validation and General Manufacturing Practices (GMP’s) as they relate to QA/QCtopics.

(PFC reserves the ability to require additional training, as recommended by the PFC Peer Review Board, toensure compliance with any changes to the AHPA and AHP guidelines, local and state regulatory updates, andduring certification renewal.)

V. Types of Certification Offered

Patient Focused Certification is available to cannabis companies in all states with medical cannabis and/or legaladult use laws in place and is designed to show the quality commitment of cannabis companies engaged inproviding patients with hemp, cannabis, and cannabis-derived products. There are several options for certifica-


tion available to companies engaged in the PFC program ranging from single discipline certification to multiplediscipline certification options. While all available PFC program certifications verify compliance with local andstate laws and regulations, as well as AHPA and AHP guidelines, some areas of certification may require addi-tional trainings and/or additional compliance criteria, such as for companies engaged in manufacturing or labo-ratory testing operations.

CULTIVATION CERTIFICATION

��• Ensures the company is compliant with state and local regulations, includinglicensing, zoning, and environmental requirements.

� �• Demonstrates the safety of products used in the cultivation process.

� �• Verifies that the raw medical cannabis does not contain an unacceptable levelof contaminants.

� �• Verifies adherence to AHPA and AHP quality standards and that procedures arein place for implementable product recall protocols, adverse event reporting,proper storage, and safe handling protocols.

� �• Determines the hazard, risk, and impact of the products used during the cultivation of medical cannabis,protecting the health and well being of the environment, employees, and patients.

� �• The Cultivation Certification process includes: comprehensive staff training, a document review, a labelreview to verify product and marketing claims, a thorough facility inspection, and laboratory testing anda contaminant review to ensure there are no unsafe levels of contaminants.

MANUFACTURING, PACKAGING, LABELING AND HOLDING CERTIFICATION

• Ensures the company is compliant with state and local regulations, licensing,zoning, and applicable environmental requirements.

� • Verifies the identity, purity, quality, and quantity of ingredients declared on theproduct label.

� • Demonstrates the product does not contain undeclared ingredients.

� • Verifies that the product does not contain an unacceptable level ofcontaminants.

� • Verifies adherence to AHPA and AHP quality standards and procedures, including product recallprotocols, adverse event recording, as well as proper packaging, labeling, storage, and handling systems.

� • Determines the hazard, risk, and impact of the products used in the medical cannabis manufacturingprocesses to ensure environmental, employee, and patient safety.

The Manufacturing, Packaging, Labeling, and Holding certification process includes: comprehensive staff train-ing; document review; a label review to verify product identity, formulation, and marketing claims; a formula-tion review to identify and quantify dietary ingredients declared on the product label; a contaminant reviewand laboratory testing to ensure there are no unsafe levels of contaminants; and a thorough facility inspection.

DISTRIBUTION CERTIFICATION

� • Ensures the company is compliant with state and local regulations, licensing,and zoning requirements.

� • Verifies adherence to AHPA and AHP quality standards and procedures,including product recall protocols, adverse event reporting , and properstorage and handling systems

� • Determines the hazard, risk, and impact of the processes used in themedical cannabis distribution operation to ensure community, employee,and patient safety.


The Distribution certification process includes: comprehensive staff training, document review, a label review toverify product formulation and marketing claims, and laboratory testing to ensure there are no unsafe levels ofcontaminants in products provided to patients.

LABORATORY CERTIFICATION

� • Ensures the company is compliant with state and local regulations,environmental, licensing, and zoning requirements.

� • Demonstrates the laboratory’s commitment to accuracy and integrity.

� • Verifies adherence to AHPA and AHP quality standards and procedures,including proper calibration, storage, and handling systems.

� • Determines the hazard, risk, and impact of the processes used in the medicalcannabis laboratory to ensure employee and patient safety.

The Laboratory Testing certification process includes: comprehensive staff training,document review, equipment and standards review, testing verification, and a thorough facility inspection.

MULTIPLE DISCIPLINE CERTIFICATION

For those companies engaged in multiple types of industry operations, PFC offersmultiple discipline certifications. This certification opportunity allows companiesengaged in a combination of cultivation, manufacturing, and/or distribution to certifyall areas with one PFC seal of approval denoting the combination of disciplines and acommitment to product safety for all aspects of their operation. In order to upholdthe integrity of PFC independent laboratory testing services and the product safetyverification such certified laboratory’s offer, PFC does NOT allow laboratory certifica-tion to be combined with other disciplined operations receiving PFC certification. If aPFC laboratory operation wishes to certify in a second discipline, then the certifiedlaboratory facility may NOT be used to satisfy the testing requirements of the second-ary discipline.

VI. Certification Process

HOW TO BECOME CERTIFIED

PFC offers a confidential and supportive certification process that includes:

1. Application—the PFC process begins when the licensee or licensee applicant provides a completedapplication to PFC. A confidential review of the business operations is completed to determineappropriate inspections and testing.

2. Quote—using information generated by the Application, PFC staff prepares a price quote and anestimate of time required for completing the certification process

3. Contract—a contract is executed outlining the responsibilities of all parties involved including financialobligations, non-disclosure protections for the applying company, and acceptance of terms.

4. Preliminary Assessment (optional)—available as PFC Advisory Services, PFC staff is available to provideprocedures for an upcoming document and physical audit and can work with management to preparethe operations facilities and processes.

5. Documentation Audit—an offsite review of company documentation determines if the company’slicensing and processes are sufficient to ensure adherence to standards.

6. Training Audit—verification of the mandatory training of all paid and volunteer employees, including allnew hires that occur over the course of the certification year. This audit is ongoing and employees musthave successfully completed all PFC required trainings prior to certification approval or renewal.


7. Document and Facility Audit—trained independent PFC field inspectors conduct a confidential PFCstandards audit and a facility inspection.

8. Product Testing— PFC tests for pesticides, molds, and contaminants with an independent third-partylaboratory when available, necessary, and appropriate for certification or complaint resolution.

9. Initial Scoring and Corrective Recommendations—the licensee receives the results of the PFC audit and isgiven corrective actions to be remedied as needed.

10. Secondary Audit—as needed

11. Certification—the PFC Review Board will issue the licensee’s certification once the PFC auditor verifiesany required corrective actions have been remedied and all compliance standards have been met.

HOW TO PREPARE FOR CERTIFICATION

Your company is ready for certification after you’ve implemented good management practices based on AHPAstandards, trained employees to become proficient with processes, and developed a sufficient evidentiary trailof documents that can be assessed. PFC staff can provide applicants with discounted training programs, as wellas document preparation and advisory services to help you company prepare for certification. Please contactPFC for additional information on advisory services.

PRELIMINARY ASSESSMENT

In many cases, the company seeking certification may request an optional preliminary assessment of their oper-ations which is offered through PFC’s Advisory Services. This gives PFC the opportunity to identify in advanceany weaknesses that may exist in the company’s management systems. A preliminary assessment gives the com-pany sufficient lead- time to correct deficiencies before audits are conducted and assists PFC in planning for thecertification. The scope of the preliminary assessment is determined by the company and may range from areview of documents to a full assessment, including on-site operational observation and assessment. While thepreliminary assessment is optional, it is recommended. Ultimately, it may save time and expense by revealingdeficiencies that, if corrected before the required audits, can save the expense of follow-up audits before certi-fication can be granted.

DOCUMENTATION AUDIT

A PFC Independent Auditor assigned to the company will retrieve all local and state licensing documents, aswell as management system documents and manuals. The assigned PFC auditor will review the documentationto determine whether it meets all requirements of local and state regulations, and the AHPA and AHP stan-dards.

Documentation should include, at a minimum:

1. Standards manual(s) – outlining systems utilized to ensure compliance with state and local law andregulations as well as the AHPA and AHP guidelines

2. Operating procedures – including detailed descriptions on how to perform system functions;

3. Work instructions – defining specific job activities affecting the safety and quality of products andprocesses; and

4. Quality documentation – documents that demonstrate how quality is managed including records, charts,files, inspection and testing records, assessment results, implementable product recall procedures,adverse event reporting, and any other records of objective evidence.

If the documentation fails to meet standards, the deficiencies will be identified in an audit report, and the licenseeis required to take corrective action before certification can be awarded. Once PFC has determined that the docu-mented management systems are satisfactory, a facility audit will be scheduled.


TRAINING AUDIT

A PFC auditor assigned to the company will verify that all paid and volunteer staff has successfully completedthe required PFC trainings. Successful completion of PFC required courses is documented by passing the corre-sponding on-line tests with a score of no less than 80%. All company staff must successfully complete therequired trainings prior to receiving certification and all new hires are required to successfully complete therequired trainings within 30 days of hire date in order for the company to maintain PFC approved company sta-tus.

FACILITY AUDIT

The assigned PFC auditor(s) will complete a thorough on-site assessment of the facility and its operations. Anaudit agenda will be prepared for the licensee prior to the arrival of the PFC auditor(s) including a daily sched-ule and any accommodation requests. It is the auditor(s) responsibility to verify whether the management sys-tems of the company meet all of the requirements of applicable standards.

Upon arrival at the facility, the PFC auditor(s) will conduct an introductory meeting followed by a full facilitywalk-through to observe activities and confirm that the operating procedures outlines in the document audithave been successfully implemented. All PFC auditors reserve the right to obtain samples for the purpose oflaboratory testing, conduct private interviews with employees, inspect documents and records, observe workprocesses, and examine equipment. The objective of the facility audit is to verify technical competency includ-ing statements, documented procedures, records, and written policies.

If deficiencies are found during the course of the audit, the PFC auditor(s) will bring the deficiencies to thelicensee’s attention and record them in the audit report as required or suggested corrective actions, dependingon the severity of the deficiency. The audit report will specifically describe, in detail, what deficiency wasobserved, the related standard or policy to which it relates, and the necessary corrective actions required toremedy the deficiency. PFC audit reports also include a recommended timeline for the company to receive certi-fication. This timeline varies depending on potential corrective actions.

PRODUCT TESTING

PFC provides a wide range of comprehensive medical cannabis product safety testing, where available (servicesmay be limited in some states). PFC’s independent laboratory testing services assist certified companies with theestablishment of product stewardship by confirming content and purity, identifying problems with contamina-tion, and determining potential for human and environmental exposure risk to ingredients and by-productsincluding potential allergens, residuals, and microbiological adulterants. The PFC program specializes in examin-ing product composition, proper packaging, labeling, and storage protocols that ensure public and patientsafety. PFC laboratory testing conducted for certification verification is provided by PFC independent certifiedlabs conforming to AHPA and AHP guidelines, as well as all applicable local and state laws and regulations.Laboratory testing for the purposes of certification verification is limited to necessary testing to meet standards.Where allowed by state law, our independent certified laboratory testing facilities can also provide patients,caregivers, and licensees cannabis analytical services as requested.

EXIT MEETING

Upon completion of the on-site audit, the assigned PFC auditor(s) will conduct an exit meeting. A summaryreview of the facility audit will be discussed with management or the primary contact person, and regulatorsas applicable. If deficiencies were recorded, they will be described at this time and included in the final facilityaudit report. All PFC applicants will be given a reasonable time period to implement any required correctiveaction(s).

CORRECTIVE ACTION

All companies with identified deficiencies will be given a reasonable timeframe to implement the mandated cor-rective action. PFC requires that all corrective actions be implemented and approved by the assigned auditorbefore certification can be granted. The corrective action response must include objective evidence, which shows


the necessary corrective actions have been completed. PFC may require a follow-up on-site facility audit, limitedto the area of concern, depending on the nature of the deficiency. Certification cannot be awarded until anyand all deficiencies have been adequately corrected.

FINAL REVIEW, REPORT AND APPEAL PROCESS

Within 10 business days of the facility audit (if no deficiencies are found) or upon confirmation of completedcorrective actions, PFC will issue a confidential report and certification decision (report will be provided to regu-lators if necessary). All documentation will be forwarded to PFC’s Peer Review Board, and the ExecutiveCommittee will review the audit report and checklist prior to issuing a decision on the certification. If the PeerReview Board grants a company certification, they are notified immediately and the appropriate certificationmaterials will be issued.

In the event that an application for PFC certification is denied, an appeal may be submitted within 10 businessdays of the issuance of the decision. PFC provides an independent Dispute Board that includes at least threemembers from the PFC Peer Review Board. Each Dispute Board member must have sufficient knowledge andexpertise in the discipline to perform a review of materials and reports and issue an impartial decision.

CERTIFICATION

Upon the successful completion of PFC required trainings, audits, and necessary corrective actions the companywill become PFC approved and will receive a PFC approved materials package. PFC certification materialsinclude:

1. A certificate bearing the certified company’s name, physical address and the PFC’s certification logo;

2. PFC certification window decals;

3. Educational and promotional materials for patients, healthcare providers and regulators;

4. PFC website links;

5. A Standards Packet including applicable AHPA guidelines and an AHP Cannabis Monograph;

6. Verification that copies of the approved certification(s) have been sent to regulators and localities, asrequired by law;

7. Annual audit reports, audit checklists and compliance updates.

Once certification has been granted, the review period begins, and the company may be subject to randomand unannounced audits and/or product testing. An annual re-certification process is mandatory. Follow-upaudits may require document submissions and/or an on-site visit. Certified companies are required to respondwithin five (5) business days to any complaint submitted to PFC (by consumers, healthcare providers, stakehold-er groups, regulators, etc.) for which a response is determined by the PFC Peer Review Board, to be necessary.PFC will maintain records of complaints on certified companies. Such complaints may trigger unannouncedinspections depending on the complaint severity and/or frequency. If for whatever reason certification must besuspended, PFC will notify regulators.

CERTIFICATION PROCESS TIMELINE

The length of time required to complete the certification process depends on several variables including: thediscipline(s) and size of facility, number of employees, and complexity of operations. The amount of time ittakes a company to achieve readiness for certification depends on the quality of management systems currentlyin place. PFC provides optional advisory services to identify and resolve documentation and process deficienciesin advance of the audit process.

The speed of the certification process is dependent upon timely and complete responses from the applicant. Atypical certification process will follow a timeline similar to the following:

1. Application Submitted


2. Quote Issuance3. Contract Execution 4. Preliminary Assessment Completion (optional)5. Documentation Audit – (3-5 business days)6. Facility Audit/Product Testing (3-5 business days)7. Corrective Action Period (if necessary) – (5-15 business days) 8. Final Review, Report and Decision – (5-10 business days)

VII. Ongoing Review & Compliance

The assigned PFC auditor and PFC staff will continually monitor certified operations throughout the annual cer-tification period. PFC is committed to working with companies engaged in the PFC Program to achieve excel-lence by providing ongoing support and monitoring of corrective actions.

In the event of a law or regulation change, or when AHPA or AHP releases updated standards, a review auditmay need to be completed. PFC staff will notify certified companies of any updates to rules, regulations, and/orstandards and provide an explanation of actions required by the company to comply with said update, includ-ing a required timeframe for compliance.

VIII. PFC Program Oversight

The PFC Program is overseen by the PFC Peer Review Board that provides over 300 years of collective expertisein the realms of USDA food and product safety protocols, federal regulatory development, medical cannabisresearch, medical cannabis industry operations, pharmacology, and biochemistry. The PFC Peer Review Board istasked with the annual review and update of audit methodologies and program standards, the processing andreview of all certification appeals, complaint investigation and resolution, and any and all revocation actions.The review board may be asked to weigh in on a company’s corrective actions as determined through either ascheduled or a secondary follow up audit. Expanded PFC Peer Review Board bios can be found at patientfo-cusedcertification.org.

PFC REVIEW BOARD

Dr. Sunil Aggarwal, M.D., Ph.D., is an Associate Member of the New York Academy of Medicineand a Resident in Physical Medicine and Rehabilitation at NYU’s Rusk Institute of RehabilitationMedicine. As a NYU Graduate Research Fellow, he conducted human studies of medical cannabisuse under the first federal Certificates of Confidentiality ever granted.

Todd Dalotto is a cannabis industry consultant, horticultural scientist, public policy advisor, andexpert witness specializing in medical cannabis. Todd is the Chair of the Oregon Health Authority’sAdvisory Committee on Medical Marijuana, chairs the ACMM’s Horticulture, Research & SafetyCommittee, and helped draft the regulations for Oregon’s licensed dispensary law.

Don Duncan has served on the Board of Directors of Americans for Safe Access since he co-found-ed it in 2002. As California Director, he is coordinating the grassroots and grasstops campaign tofully implement the state’s medical marijuana laws, respond to federal interference, and build abroader, more powerful coalition for medical marijuana. Don co-founded one of the oldest andmost reputable families of medical cannabis dispensing collectives in California, helping to open

legal facilities in Berkeley, West Hollywood, and Los Angeles.

Dr. Robert L. Epstein served as Associate Administrator and Chief Operating Officer for theAgricultural Marketing Service, U.S. Department of Agriculture (USDA) from January 2013 until hisretirement in June 2013. With over 34 years of service at the USDA Dr. Epstein has held variousleadership positions involving food safety, laboratory services, toxicology, residue chemistry, andquality assurance.


Jill Lamoureux has a background in toll road operation and municipal bond finance, and anMBA from the University of Denver. She is a founding member of, and served as the first womanChair of the National Cannabis Industry Association and has been a leader in Colorado’s medicalmarijuana industry since. Jill developed Patient Focused Certification with Americans for SafeAccess and serves as Chair of the PFC Peer Review Board.

Philippe G. Lucas holds a master’s degree in the area of Studies in Policy and Practice from theUniversity of Victoria and is co-owner and COO of the Canadian Cannabis Research Institute.Philippe has also served as a co-investigator for Medical Cannabis Standards, Engagement,Evaluation, and Dissemination (SEED) Project, and served on the Victoria City Council from Nov2008-Nov 2011.

Jahan Marcu, Ph.D. is the Vice-Chair of the Americans for Safe Access Multidisciplinary ScientificAdvisory Board and is currently investigating the pharmacology of cannabinoid receptors atTemple University. He received his Ph.D. for studying the structure and function of the CB1 recep-tor, and the role of the endocannabinoid system in bone.

Michael McGuffin is President of the AHPA and Managing Editor of AHPA’s Botanical SafetyHandbook, and of Herbs of Commerce, second edition (2000). He serves on the boards of the AHPand United Plant Savers, and on the Advisory Board of the USC School of Pharmacy RegulatoryScience Master’s Degree Program.

Kristin Nevedal is Director of PFC and chairs the AHPA Cannabis Committee’s Cultivation WorkingGroup, assisting in the development of model cultivation regulations and best practices for agencyconsideration. She is also an instructor at Oaksterdam University, teaching classes on environmentalsustainability and Best Management Practices, as well as Co-Founder and Chair of the EmeraldGrowers Association.

Dr. Michelle Sexton is a naturopathic doctor, herbalist, educator and clinical cannabis researcher.Dr. Sexton completed a postdoctoral fellowship focused on the endogenous cannabinoid signalingsystem (ECS) in the Departments of Pharmacology and Psychiatry and Behavioral Medicine at theUniversity of Washington. Michelle is also research faculty at Bastyr University research instituteand Technical Advisor to the American Herbal Pharmacopoeia.

Steph Sherer is a medical marijuana patient with over 15 years managing non-profit businessesand community organizations including: event planning, consulting, fund development, publicrelations, and project management. Steph is a powerful advocate, a skilled spokesperson, an ener-getic initiator of campaigns, and a nationally recognized activist in the global justice movementand a guest lecturer at the University of California, Berkeley and George Washington University,DC.

Tim Smale is the Co-Founder and Executive Director of Remedy Compassion Center in Auburn,Maine and a results-driven leader with over 30 years domestic and international experience withnonprofit and for profit organizations, from small businesses to Fortune 100 companies.

E� lan M. Sudberg, CEO of Alkemist Labs, holds a degree in chemistry and has authored numerousjournal articles on phytochemistry. He is the instructor of AHPA’s Seminar on MicroscopicIdentification of Popular Botanical Materials, an appointed board of trustees member of AHPA, aboard member of AHPA’s ERB Foundation, and the former Chair of the Hemp and MedicalMarijuana Committee. He serves as a Technical Adviser for the AHP.

Dr. Jim Tozzi worked for five consecutive presidential administrations, including service as the sen-ior career regulatory policy official at the White House Office of Management and Budget. Dr.Tozzi is the father of the Data Quality Act and has been appointed to the AdministrativeConference of the US overseeing the federal regulatory process.


IX. PFC Auditor Qualifications

PFC independent auditors have extensive experience in the medical cannabis industry or in auditing similarindustry and/or the herbal products industries. All PFC independent auditors are required to successfully com-plete the PFC trainings and are assigned a mentor to oversee PFC audits until such time as the mentoring audi-tor can verify the trainees’ readiness to audit without mentor oversight. All auditor trainees are required toconduct a minimum of two audits per discipline with his or her mentor before being allowed to audit inde-pendently.

All PFC Cultivation and Processing auditors must have five years or more direct experience in the field of med-ical cannabis cultivation and processing or five years or more direct experience in the field of agriculturalinspection and must demonstrate a thorough understanding of the standard operating systems associated withall modalities of cannabis cultivation.

Manufacturing, packaging, labeling, and holding auditors must have five years or more direct experience in thefield of medical cannabis manufacturing and are required to be food-safe certified; or have three years or moredirect experience in the inspection and auditing of facilities engaged in the manufacturing of food, food prod-ucts, or botanical and nutraceutical products. In addition, all manufacturing, packaging, labeling, and holdingauditors must also demonstrate a fundamental knowledge of any extraction processes used in the medicalcannabis industry.

PFC Laboratory auditors must have, at minimum, a degree in biochemistry; or a minimum of five years experi-ence providing laboratory analysis of medical cannabis and medical cannabis-derived products the equivalentexperience providing laboratory analysis of other raw botanicals, botanical products, or nutriceutical products.

Dispensary auditors must have, at a minimum, three years of direct experience in managing a medical cannabisdistribution facility offering patient services, or the equivalent experience offering patient services and manag-ing a traditional or Complementary Alternative Medicine facility.

X. Fees and Discounts

Each applicant has its own unique characteristics that will determine the cost of certification. Two key elementscomprise the cost of certification: size and complexity of the operations. As the size of a company increasesso does the number of patients or consumers engaging in the company’s services or products. PFC’s patientand caregiver education program serves to provide your business with plenty of educational materials designedto help consumers understand the importance of the PFC seal of approval.

All quotes also include the cost of the initial pre-certification audit plus the required compliance audit. As acompany grows in size and possibly in complexity of operations so does the amount of time necessary to con-duct a thorough audit of the company’s operations. For example, a company that dispenses medical cannabisoften requires much less time to conduct an audit than a company that cultivates and manufactures medicalcannabis. As such these scalable costs are reflected in the PFC quote.

PFC will provide a quote after a complete review of your application. This quote is an estimated cost and willinclude:

1. Fees for preliminary assessment (optional)

2. Fees for the initial audit plus one unannounced compliance audit and certification review

3. Fees for certification including graphics and promotional literature

4. Fees for ongoing compliance including complain hotline, complaint investigation, and possiblecertification challenges

PFC is committed to providing your company with a quality certification program that adds value to your busi-ness. We are committed to providing the most qualified inspection and audit team at the lowest cost possible.The program’s value drivers include:


1. No application fee

2. Discounts for some trade association members, AHPA members, and UFCW contracted businesses.

3. No mandatory preliminary site visit

4. No hidden costs, overtime charges, or penalties for properly noticed schedule changes

5. Reimbursable expenses are charged at cost without mark-ups

6. Advanced off-site preparation is completed by PFC, reducing travel time required

7. Audits include a review of compliance with local and state regulations

8. Press release development by PFC outreach staff

9.` Advertisement of your participation in all PFC ads

Discount Opportunity: PFC is pleased to offer discounts to members of organizations that have endorsed thePFC program. Endorsing organization discounts can be combined to provide your business with a maximum15% discount on certification. PFC can also offer group discounts for organizations that want certify 10 mem-bers, or more, at a given time. For more information on endorsing organizations please see the website:www.patientfocusedcertification.org

Endorsement Opportunity for Trade Associa-tions and other Accrediting Groups: PFC recognizes theimportance of endorsing organizations ongoing work with their members to insure compliance with local andstate regulatory guidelines. As such, PFC is pleased to offer discounts to organizations working directly withthe PFC program. Once PFC has approved your association’s or accrediting group’s endorsement , PFC will hap-pily offer all members and companies acknowledged by your group a 5% discount on PFC certification.

XI. About ASA, AHPA and AHP

Founded in 2002, Americans for Safe Access (ASA) is the largest organization ofpatients, medical professionals, scientists and concerned citizens promoting safeand legal access to medical cannabis. ASA’s mission is to ensure safe and legalaccess to cannabis (marijuana) for therapeutic uses and research. ASA works with

our grassroots base of over 50,000 members to effect change using public education and direct advocacy at thelocal, state, and federal level. ASA trains and educates patients, advocates, health care professionals and otherstakeholders. ASA also provides direct legal support and uses impact litigation to protect and expand patients’rights.

As patient advocates, ASA has worked to create laws and regulations that foster the rights of patients, andensure access to safe and legal medical cannabis. Now, through PFC, patients, caregivers, and health care practi-tioners, as well as state and local regulators, can rely on the PFC seal of approval and know the medicalcannabis or cannabis-derived product has been produced in a manner that is not only compliant with local andstate laws but also with a commitment to product safety. To learn more about ASA go to: www.americansfor-safeaccess.org.

The American Herbal Products Association chartered a Cannabis Committee in 2010to meet the needs its members who cultivate, manufacture, or distribute medicalcannabis in the states where its use is allowed by state law, and of companies thatmarket industrial hemp products. AHPA has been the principal U.S. trade associa-

tion and voice of the herbal products industry since 1982. AHPA promotes the economic health of the herbalproducts industry and promotes high quality herbal and nutraceutical products. AHPA serves its members bypromoting the responsible commerce of products that contain herbs and that are used to enhance health andquality of life. To learn more about AHPA go to: www.ahpa.org.

The American Herbal Pharmacopoeia was formed in 1994 to promote the respon-sible use of herbal products and herbal medicines. AHP is a worldwide network ofbotanists, chemists, herbalists, medical doctors, pharmacists, pharmacologists, and


other experts in medicinal plants. AHP has published monographs for 28 different botanicals, including AloeVera Leaf, American Ginseng Root, and Echinacea. The organization expects to eventually publish more than300 monographs, covering the most widely used western, Ayurvedic, and Chinese botanicals. To learn moreabout the AHP go to: www.herbal-ahp.org.

XII. Frequently Asked Questions

What is Third-Party Certification?

Third-party certification ensures that an independent organization has reviewed the cultivation and/or manu-facturing process of a product or the management process of a service in order to determine that the finalproduct complies with a specific set of standards designed to ensure safety, quality, or performance. PFC certi-fies compliance with AHPA and AHP standards for medical cannabis products and services. This review typicallyincludes comprehensive reviews of formulations and materials, independent testing, and facility inspections.Certified products typically exhibit the certifier’s ‘mark’ on their packaging to help consumers make educateddecisions about the products or services they are purchasing. PFC requires annual inspections, unannouncedrandom inspections, employee training and product testing to ensure that certified companies continue tomeet all AHPA standards after the initial certification. Other nationally recognized certification programsinclude Good Housekeeping, NSF and ISO.

What is the difference between PFC and ISO 17025 for Lab Certification?

ISO compliance will help an operator pass a PFC inspection. ISO 17025 accreditation ensures compliance with aspecific set of laboratory methods, PFC compliance ensures compliance with botanical health and safety stan-dards, and criteria for validating specific methods. Both PFC and ISO require significant documentation andmethod validation, but ISO depends on the operators being forthright whereas PFC compliance hinges on theoperator providing requested documentation i.e. ISO (e.g., 17025) audits whatever an operator presents as partof a “quality manual.” There could be a 1,000 procedures being used in the lab and only 1 could be in thequality manual. For an ISO audit, an operator is expected to show/help auditors identify “conflict” or correctiveaction areas, while PFC asks for specific criteria provided by the AHPA’s Recommendations to Regulators andthe AHP Cannabis Monograph..

ISO is used for commercial labs operating outside stateliness, laboratories are encouraged to get ISO but eventheir guidebooks suggest that local guidelines and standards are important for operating locally, if such guide-lines are available. ISO is often used when there is absence of a compliance or certification body, such as in asmall country with a few labs.

ISO is context deficient for medical cannabis operators. It doesn't tell you if the business is a good cannabisoperation or not because it only informs on what is needed to do an aspect of their work, regardless if it islegal or meant for human consumption. PFC offers training in specific areas of cannabis that are used by opera-tors and health department inspectors in compliance audits, ISO does not require that the staff be trained inspecific areas essential for operation in the cannabis industry. Sample handling, storage, security, legal opera-tions issues (ISO does not check licensing or permits from the state) are examples of best practices and regulato-ry requirements that ISO does not fully address for the cannabis industry.

Analytical Chemistry cannot be properly dealt with if its relationships with written standards are not taken intoaccount in order to efficiently contribute to the continuous improvement of human activities.

…the key issue in selecting an accreditation body is to ensure that it has recognition in the context inwhich the laboratory’s data needs to be used. Where a laboratory operates purely in a domestic marketand where the data is used only within the country, for example for local food safety or environmentalprotection, then a national accreditation body, even one with no international recognition, will normallybe entirely suitable.

(From “Complying with ISO 17025: A practical guidebook for meeting the requirements �of laboratory accreditation schemes based on ISO17025:2005� or equivalent national standards published by (United Nations Industrial Development Organization)

Difference Between PFC and ISO for Lab Certification

PFC and ISO Harmonization

• Mutual Recognition Agreements (MRAs), ISO:17011 compliance• European Cooperation for the Accreditation of Laboratories (EAL)

• Asia Pacific Accreditation Cooperation (APLAC) • Quality Systems Training• Method Validation reports• Audits

CONFIDENTIA

L

APPLICATIONPatient Focused Certification

For your free quote, please completely fill out the application below. Upon completion, andsubmitting the application, your company’s information will be securely transmitted to PFCstaff. You will automatically receive a confirmation email verifying that PFC has received yourapplication and inviting you to create a secure PFC client profile where you can safely viewand store documents to track your company’s certification process. Within 7 business days,PFC staff will send you a price quote and contract that will list the responsibilities of all partiesinvolved including financial obligations, nondisclosure agreements and acceptance of terms.

Business Trade Name (required) ____________________________________________________________________

Business Legal Name (required) ____________________________________________________________________

Mailing Street Address:___________________________________________________________________________

City: ______________________________________________ State:__________ Zip:_____________________

Primary Contact Name (required) ______________________________________________

Primary Contact Email (required) ______________________________________________

Primary Contact Phone (required)______________________________________________

Number of Facilities (required) ________________________________(Organizations with multiple locations, please fill out Additional Locations section at the end of the application.)

Number of Employees (required) _______________________________

A. Service Requested (check all that apply) � Advisory Services � Pre-Licensing Certification � Industry Certification

B. Facilities to be Certified / Types of Certification Sought (check one)

� Cultivation � Distribution � Manufacturing � Laboratory � Cultivation & Distribution

� Cultivation & Manufacturing � Manufacturing & Distribution � Cultivation, Manufacturing, & Distribution

How many square ft of cultivated space (if applicable)

� 0-5,000 � 5,000-10,000 � 10,000-20,000 � 20,000-40,000 � 40,000 or above

Number of products manufactured (if applicable): _____________

Please describe the types of products to be manufactured (choose all that apply)

� Extracts/Concentrates � Edible or Ingestible Products � Topical Products

Additional Product Information__________________________________________________________________

_________________________________________________________________________________________

C. Licensing. Please describe the state and local licensing or registrations relevant to your operations. Please note if no li-

censes are available for your operation. ___________________________________________________________

_________________________________________________________________________________________

_________________________________________________________________________________________

CONFIDENTIA

L

PATIENT FOCUSED CERTIFICATION APPLICATION ~ Page 2 of 3

D. MACHINERY AND INFRASTRUCTUREPlease describe the major machinery, software and infrastructure used in your operations. Thismight include inventory and tracking software, manufacturing equipment, trim machines, etc.

____________________________________________________________________________________________

____________________________________________________________________________________________

____________________________________________________________________________________________

____________________________________________________________________________________________

E. SUBCONTRACTORSIf applicable, please list any sub-contractors used in your operations, including name and the activi-ties they perform. Examples of sub-contractors include the nursery that provides the company’spropagation material. Or, if manufacturing edible products, the name of the company who sup-plies your company with extracted cannabis products.

____________________________________________________________________________________________

____________________________________________________________________________________________

____________________________________________________________________________________________

____________________________________________________________________________________________

F. OTHER CERTIFICATIONSPlease list any certifications, past or present, your operation has received and the name of the certi-fying organization. If cancelled or no longer current, please describe why.

____________________________________________________________________________________________

____________________________________________________________________________________________

G. ORGANIZATION AFFILIATIONCompanies with membership in AHPA, various trade organizations, or those under UFCW contractsare eligible for discounts. Please choose all that apply:

� American Herbal Products Association

� United Food & Commercial Workers Union

� Emerald Growers Association

� International Hemp Association

� Coalition for Cannabis Standards and Ethics

Please list additional organizational memberships or affiliations: ________________________________

____________________________________________________________________________________________

____________________________________________________________________________________________

If you belong to an organization or association whose members would benefit from a discount,please contact us for details. [email protected]

CONFIDENTIA

L

PATIENT FOCUSED CERTIFICATION APPLICATION ~ Page 3 of 3

PATIENT FOCUSED CERTIFICATION, a project of Americans for Safe Access1806 Vernon Street NW, Washington, D.C. 20009

Phone: (202) 857-4272 Fax: (202) 618-6977

H. ADDITIONAL LOCATIONS

Name _______________________________________________________________________________________

Address:______________________________________________________________________________________

City: ______________________________________________ State:__________ Zip:_____________________

Type (choose one): � Cultivation � Distribution � Manufacturing

Number of Employees __________________________________

Name _______________________________________________________________________________________

Address:______________________________________________________________________________________

City: ______________________________________________ State:__________ Zip:_____________________



Name _______________________________________________________________________________________

Address:______________________________________________________________________________________

City: ______________________________________________ State:__________ Zip:_____________________



I. Where did you hear about us?

� Mail � Peer � Internet

� Organization or Association (Please list): ____________________________________________________

� Other: ___________________________________________________________________________________

All application information shall remain CONFIDENTIAL. Based on the information contained inthis application, PFC will prepare a no-obligation offer for certification. If PFC staff requires additional information to generate a quote, a representative will contact you directly via email.

A1.

1 (b

) • S

ubje

ct o

pera

tions

– D

oes t

his c

ultiv

atio

n op

erat

ion

also

incl

ude

a

proc

essi

ng o

pera

tion?

☐

☐

☐

A1.

1 (a

) • S

ubje

ct o

pera

tions

– Is

this

ope

ratio

n su

bjec

t to

stat

e an

d/or

loca

l ov

ersi

ght?

☐

☐

☐

A1.

2 • O

ther

stat

utor

y pr

ovis

ions

and

reg

ulat

ions

– Is

this

ope

ratio

n co

mpl

iant

with

all

appl

icab

le re

gula

tions

in th

e ju

risdi

ctio

n it

oper

ates

? (e

.g.

has a

lice

nse

in g

ood

stan

ding

, cer

tific

ate

of o

ccup

ancy

, con

fiden

tialit

y re

quire

men

ts, l

abel

ing

and

test

ing

requ

irem

ents

, etc

.)

☐

☐

☐

B2.

1(a)

(1) O

pera

tions

– D

oes t

he o

pera

tion

incl

ude

indo

or c

ultiv

atio

n op

erat

ions

?

☐

☐

☐

B2.

1(a)

(2) O

pera

tions

– D

oes t

he o

pera

tion

incl

ude

gree

nhou

se c

ultiv

atio

n op

erat

ions

? ☐

☐

☐

SAMPLE

B2.

1(a)

(3) O

pera

tions

– D

oes t

he o

pera

tion

incl

ude

outd

oor c

ultiv

atio

n op

erat

ions

? ☐

☐

☐

B2.

1(a)

(4) O

pera

tions

– D

oes t

he o

pera

tion

incl

ude

nurs

ery

oper

atio

ns?

☐

☐

☐

B2.

1(b)

(1) O

pera

tions

– D

oes t

his o

pera

tion

prod

uce

its o

wn

cann

abis

pl

antin

g m

ater

ial?

☐

☐

☐

B2.

1(b)

(2)(

i) O

pera

tions

– D

oes t

his o

pera

tion

obta

in c

anna

bis p

lant

ing

mat

eria

l fro

m o

ther

cul

tivat

ion

oper

atio

ns?

☐

☐

☐

B2.

1(b)

(2)(

ii) O

pera

tions

– D

oes t

his o

pera

tion

obta

in c

anna

bis f

rom

a

nurs

ery

oper

atio

n?

☐

☐

☐

B2.

1(b)

(2)(

ii) O

pera

tions

– D

oes t

his o

pera

tion

obta

in c

anna

bis f

rom

co

mpl

iant

indi

vidu

als?

☐

☐

☐

B2.

1(c)

(1) O

pera

tions

– If

this

faci

lity

cont

ains

a p

roce

ssin

g op

erat

ion,

is

cann

abis

obt

aine

d fro

m a

cul

tivat

ion

oper

atio

n?

☐

☐

☐

B2.

1(c)

(2) O

pera

tions

– If

this

faci

lity

cont

ains

a p

roce

ssin

g op

erat

ion,

is

cann

abis

obt

aine

d fro

m c

ompl

iant

indi

vidu

als?

☐

☐

☐

B2.

1(c)

(3) O

pera

tions

– If

this

faci

lity

cont

ains

a p

roce

ssin

g op

erat

ion,

is

cann

abis

obt

aine

d fro

m v

endo

rs?

☐

☐

☐

B2.

1(d)

(1) O

pera

tions

– D

oes t

his o

pera

tion

dist

ribut

e ca

nnab

is to

oth

er

culti

vatio

n op

erat

ions

? ☐

☐

☐

B2.

1(d)

(2) O

pera

tions

– D

oes t

his o

pera

tion

dist

ribut

e ca

nnab

is to

oth

er

proc

essi

ng o

pera

tions

? ☐

☐

☐

B2.

1(d)

(3) O

pera

tions

– D

oes t

his o

pera

tion

dist

ribut

e ca

nnab

is to

ope

ratio

ns

with

dis

tribu

tion

prac

tices

or d

ispen

sing

ope

ratio

ns?

☐

☐

☐

SAMPLE

B2.

1(d)

(4) O

pera

tions

– D

oes t

his o

pera

tion

dist

ribut

e ca

nnab

is to

m

anuf

actu

ring

oper

atio

ns?

☐

☐

☐

B2.

1(d)

(5) O

pera

tions

– D

oes t

his o

pera

tion

dist

ribut

e ca

nnab

is to

ven

dors

? ☐

☐

☐

B2.

1(d)

(6) O

pera

tions

– D

oes t

his o

pera

tion

dist

ribut

e ca

nnab

is to

com

plia

nt

indi

vidu

als?

☐

☐

☐

B2.

2(a)

(1) O

pera

tions

– D

oes t

his o

pera

tion

also

eng

age

in a

ncill

ary

oper

atio

ns su

ch a

s the

man

ufac

turin

g, p

acka

ging

, lab

elin

g, a

nd/o

r hol

ding

of

cann

abis

-der

ived

pro

duct

s? (I

ndic

ate

all t

hose

that

app

ly b

y ci

rclin

g th

e an

cilla

ry o

pera

tion

in th

e lis

t abo

ve.)

☐

☐

☐

B2.

2(a)

(2) O

pera

tions

– D

oes t

his o

pera

tion

also

eng

age

in la

bora

tory

op

erat

ions

? ☐

☐

☐

B2.

2(a)

(3) O

pera

tions

– D

oes t

his o

pera

tion

enga

ge in

dis

tribu

tion

prac

tices

fo

r can

nabi

s and

can

nabi

s-de

rived

pro

duct

s?

☐

☐

☐

B2.

2(a)

(4) O

pera

tions

– D

oes t

his o

pera

tion

enga

ge in

cul

tivat

ion

and

mar

ketin

g of

pro

duct

s oth

er th

an c

anna

bis?

☐

☐

☐

B2.

3(a)

(1) C

ultiv

atio

n pr

actic

es –

Are

all

prop

agat

ion

mat

eria

ls u

sed

in

culti

vatio

n op

erat

ions

app

rove

d fo

r use

in fo

od p

rodu

ctio

n?

☐

☐

☐

B2.

3(a)

(1) C

ultiv

atio

n pr

actic

es –

Are

all

prop

agat

ion

mat

eria

ls h

andl

ed

follo

win

g th

e m

anuf

actu

rer’

s usa

ge, s

tora

ge, a

nd d

ispos

al re

com

men

datio

n?

☐

☐

☐

B2.

3(b)

(1)(

i-iv)

Cul

tivat

ion

prac

tices

– Is

the

oper

atio

n co

mpl

iant

with

pe

rmitt

ed u

se o

f pes

ticid

es a

s rec

omm

ende

d in

Sec

tion

2.3B

(1)(

i-iv)

and

any

ot

her a

pplic

able

regu

latio

ns fo

r the

ir ju

risdi

ctio

n?

☐

☐

☐

SAMPLE

B2.

3(b)

(2) C

ultiv

atio

n pr

actic

es –

Is th

e op

erat

ion

follo

win

g th

e m

anuf

actu

rer’

s app

licat

ion

and

stora

ge re

com

men

datio

ns, a

nd d

ispo

sal

reco

mm

enda

tions

, for

any

pes

ticid

e pr

oduc

ts?

☐

☐

☐

B2.

3(b)

(3) C

ultiv

atio

n pr

actic

es –

Is th

e op

erat

ion

follo

win

g th

e EP

A

Wor

ker P

rote

ctio

n St

anda

rd w

hen

prep

arin

g an

d ap

plyi

ng p

estic

ides

? ☐

☐

☐

B2.

3(b)

(4) C

ultiv

atio

n pr

actic

es –

If th

is o

pera

tion

is in

door

, is i

t com

plyi

ng

with

the

pest

icid

e m

anuf

actu

rer’

s pub

lishe

d re

-ent

ry in

terv

al ti

me

perio

ds

whe

n ap

plyi

ng p

estic

ides

?

☐

☐

☐

B2.

3(c)

(1) C

ultiv

atio

n pr

actic

es –

Are

the

nutri

ents

use

d in

cul

tivat

ion

appr

opria

te fo

r use

in fo

od p

rodu

ctio

n? (N

ot re

quire

d by

AH

PA d

ocum

ent.)

☐

☐

☐

B2.

3(c)

(2) C

ultiv

atio

n pr

actic

es –

Is th

e op

erat

ion

follo

win

g th

e m

anuf

actu

rer’

s app

licat

ion,

stor

age,

and

disp

osal

reco

mm

enda

tions

for t

he

nutri

ent p

rodu

ct?

☐

☐

☐

B2.

3(c)

(3) C

ultiv

atio

n pr

actic

es –

Is th

e op

erat

ion

retu

rnin

g un

used

pla

nt

solu

tions

(e.g

., ro

otin

g ho

rmon

e) to

the

sour

ce c

onta

iner

? (N

ot a

llow

ed.)

☐

☐

☐

B2.

3(c)

(4) C

ultiv

atio

n pr

actic

es –

Are

nitr

ate-

base

d an

d ot

her o

xidi

zing

fe

rtiliz

ers s

tore

d aw

ay fr

om so

lven

ts, f

uels

, and

pes

ticid

es?

☐

☐

☐

B2.

3(d)

(1) C

ultiv

atio

n pr

actic

es –

If th

e op

erat

ion

is in

door

, are

car

bon

diox

ide

leve

ls k

ept u

nder

200

0 pp

m w

hen

faci

lity

pers

onne

l may

be

pres

ent i

n cu

ltiva

tion

area

s?

☐

☐

☐

B2.

3(d)

(2) C

ultiv

atio

n pr

actic

es –

Is th

e in

door

cul

tivat

ion

faci

lity

utili

zing

ca

rbon

dio

xide

at l

evel

s abo

ve 2

000

ppm

in a

seal

ed ro

om?

If so

, is t

here

pr

otec

tive

equi

pmen

t pro

vide

d fo

r per

sonn

el a

nd w

arni

ng si

gns

pres

ent t

o pr

even

t oth

er p

erso

nnel

from

ent

erin

g?

☐

☐

☐

B2.

3(d)

(3) C

ultiv

atio

n pr

actic

es –

Are

all

regu

lato

rs a

nd e

nviro

nmen

tal

cont

rol s

yste

ms t

hat r

egul

ate

carb

on d

ioxi

de e

mis

sion

s in

good

wor

king

ord

er

☐

☐

☐

SAMPLE

and

serv

iced

in a

ccor

danc

e w

ith th

e m

anuf

actu

rer’

s rec

omm

enda

tions

?

B2.

3(e)

(1) C

ultiv

atio

n pr

actic

es –

Is e

quip

men

t use

d fo

r mea

surin

g,

regu

latin

g, o

r rec

ordi

ng te

mpe

ratu

res,

pH, h

umid

ity, o

r oth

er c

ondi

tions

re

late

d to

the

culti

vatio

n an

d pr

oces

sing

of c

anna

bis a

ccur

ate

and

adeq

uate

ly

mai

ntai

ned

(as e

vide

nt b

y do

cum

enta

tion

or m

onito

ring

in a

mai

ntai

ned

log)

?

☐

☐

☐

B2.

3(e)

(2) C

ultiv

atio

n pr

actic

es –

Are

cul

tivat

ion

and

proc

essi

ng to

ols t

hat

com

e in

dire

ct c

onta

ct w

ith c

anna

bis p

lant

s dis

infe

cted

as n

eede

d?

☐

☐

☐

B2.

3(e)

(3) C

ultiv

atio

n pr

actic

es –

Are

scal

es u

sed

for t

he w

eigh

ing

of

cann

abis

cal

ibra

ted

at re

gula

r int

erva

ls?

☐

☐

☐

B2.

4(a)

Pro

cess

ing

prac

tices

– A

re a

ll w

ork

surf

aces

and

equ

ipm

ent c

lean

an

d sa

nita

ry?

☐

☐

☐

B2.

4(b)

Pro

cess

ing

prac

tices

– A

re th

ere

prot

ocol

s in

plac

e w

hich

pre

vent

pr

oces

sing

con

tam

inat

ion

and

mol

d an

d m

ildew

gro

wth

on

cann

abis?

☐

☐

☐

B2.

4(c)

Pro

cess

ing

prac

tices

– A

re fa

cem

asks

and

glo

ves u

sed

by e

mpl

oyee

s ha

ndlin

g ca

nnab

is in

goo

d op

erab

le c

ondi

tion,

as a

pplic

able

to jo

b fu

nctio

n?

☐

☐

☐

B2.

4(d)

Pro

cess

ing

prac

tices

– D

o em

ploy

ees w

ash

hand

s suf

ficie

ntly

whe

n ha

ndlin

g ca

nnab

is o

r use

glo

ves (

with

pro

per a

nti-s

eptic

tech

niqu

es)?

☐

☐

☐

B2.

5(1)

Dis

trib

utio

n pr

actic

es –

Is th

e ca

nnab

is di

strib

uted

by

the

oper

atio

n ac

com

pani

ed w

ith th

e cu

ltiva

tion

or p

roce

ssin

g op

erat

ion’

s nam

e?

☐

☐

☐

B2.

5(2)

Dis

trib

utio

n pr

actic

es –

Is th

e ca

nnab

is di

strib

uted

by

the

oper

atio

n ac

com

pani

ed w

ith th

e ap

prop

riate

info

rmat

ion

for t

he id

entit

y of

the

cont

ents

? ☐

☐

☐

B2.

5(3)

Dis

trib

utio

n pr

actic

es –

Is th

e ca

nnab

is di

strib

uted

by

the

oper

atio

n ac

com

pani

ed w

ith th

e ap

prop

riate

info

rmat

ion

for t

he n

et w

eigh

t of c

onte

nts?

☐

☐

☐

B2.

5(4)

Dis

trib

utio

n pr

actic

es –

Is th

e ca

nnab

is di

strib

uted

by

the

oper

atio

n ☐

☐

☐

SAMPLE

acco

mpa

nied

with

suffi

cien

t inf

orm

atio

n to

trac

e th

e ca

nnab

is to

its b

atch

?

C3.

1(a)

(1) P

erso

nnel

– D

oes t

he o

pera

tion

ensu

re th

at a

ll em

ploy

ees h

ave

educ

atio

n, tr

aini

ng, a

nd e

xper

ienc

e, o

r any

com

bina

tion

ther

eof,

to e

nabl

e th

at

pers

on to

per

form

all

assi

gned

func

tions

?

☐

☐

☐

C3.

1(a)

(2) P

erso

nnel

– A

re th

ere

reco

rds o

f tra

inin

gs p

rovi

ded

to e

mpl

oyee

s fo

r the

per

form

ance

of a

ll as

sign

ed fu

nctio

ns?

☐

☐

☐

C3.

1(b)

(1) P

erso

nnel

– D

oes t

he o

pera

tion

prov

ide

all e

mpl

oyee

s with

tra

inin

g re

gard

ing

regu

lato

ry in

spec

tion

prep

ared

ness

?

☐

☐

☐

C3.

1(b)

(1) P

erso

nnel

– D

oes t

he o

pera

tion

prov

ide

all e

mpl

oyee

s with

tra

inin

g re

gard

ing

law

-enf

orce

men

t int

erac

tions

? ☐

☐

☐

C3.

1(b)

(2) P

erso

nnel

– D

oes t

he o

pera

tion

prov

ide

all e

mpl

oyee

s with

tra

inin

g re

gard

ing

U.S

. fed

eral

law

s, re

gula

tions

, and

pol

icie

s rel

atin

g to

in

divi

dual

s em

ploy

ed in

thes

e op

erat

ions

, and

the

impl

icat

ions

of t

hese

for

such

em

ploy

ees?

☐

☐

☐

C3.

1(c)

(1) P

erso

nnel

– D

oes t

he o

pera

tion

impl

emen

t em

ploy

ee h

ygie

ne

prot

ocol

s and

trai

ning

, whi

ch a

t a m

inim

um a

ddre

ss p

olic

ies w

hich

pro

hibi

t em

ploy

ees w

ho a

re sh

owin

g si

gns o

f illn

ess,

open

wou

nds,

sore

s, o

r ski

n in

fect

ions

from

han

dlin

g ca

nnab

is?

☐

☐

☐

C3.

1(c)

(2) P

erso

nnel

– D

oes t

he o

pera

tion

impl

emen

t em

ploy

ee h

ygie

ne

prot

ocol

s and

trai

ning

, whi

ch a

t a m

inim

um a

ddre

ss h

ygie

ne tr

aini

ng fo

r em

ploy

ees w

ho h

andl

e ca

nnab

is w

ith sp

ecifi

c at

tent

ion

to p

reve

ntin

g m

icro

bial

con

tam

inat

ion

(incl

udin

g a

mic

robi

al c

onta

min

atio

n pr

even

tion

man

ual o

n ha

ndlin

g ca

nnab

is a

sept

ical

ly)?

☐

☐

☐

C3.

1(c)

(3) P

erso

nnel

– D

oes t

he o

pera

tion

impl

emen

t em

ploy

ee h

ygie

ne

prot

ocol

s and

trai

ning

, whi

ch a

t a m

inim

um a

ddre

ss h

and

was

hing

re

quire

men

ts in

clud

ing

was

hing

han

ds w

ith so

ap a

nd h

ot w

ater

bef

ore

begi

nnin

g w

ork,

afte

r usi

ng th

e ba

thro

om, a

nd a

fter m

eal b

reak

s?

☐

☐

☐

SAMPLE

C3.

1(c)

(4) P

erso

nnel

– D

oes t

he o

pera

tion

have

han

d w

ashi

ng si

gnag

e in

ap

prop

riate

are

as su

ch a

s bat

hroo

ms,

kitc

hens

, and

lunc

h ar

eas,

and

in m

ultip

le

lang

uage

s as n

eede

d?

☐

☐

☐

C3.

2(a)

Em

ploy

ee sa

fety

– D

oes t

he o

pera

tion

impl

emen

t saf

ety

prot

ocol

s an

d pr

ovid

e al

l em

ploy

ees w

ith a

dequ

ate

safe

ty tr

aini

ng re

leva

nt to

thei

r sp

ecifi

c jo

b fu

nctio

ns?

☐

☐

☐

C3.

2(a)

(1) E

mpl

oyee

safe

ty –

Doe

s the

ope

ratio

n pr

ovid

e em

ploy

ees w

ith

emer

genc

y ac

tion

resp

onse

pla

nnin

g as

nec

essa

ry?

☐

☐

☐

C3.

2(a)

(2) E

mpl

oyee

safe

ty –

Doe

s the

ope

ratio

n pr

ovid

e tra

inin

g an

d pr

otoc

ols f

or e

mpl

oyee

acc

iden

t rep

ortin

g an

d in

vest

igat

ion

polic

ies?

☐

☐

☐

C3.

2(a)

(3) E

mpl

oyee

safe

ty –

Doe

s the

ope

ratio

n pr

ovid

e tra

inin

g an

d pr

otoc

ols f

or fi

re p

reve

ntio

n?

☐

☐

☐

C3.

2(a)

(4) E

mpl

oyee

safe

ty –

Doe

s the

ope

ratio

n pr

ovid

e tra

inin

g an

d pr

otoc

ols f

or h

azar

d co

mm

unic

atio

n po

licie

s, in

clud

ing

mai

nten

ance

of

mat

eria

l saf

ety

data

shee

ts (M

SDS)

?

☐

☐

☐

C3.

2(a)

(5) E

mpl

oyee

safe

ty –

Doe

s the

ope

ratio

n pr

ovid

e tra

inin

g an

d pr

otoc

ols f

or m

ater

ials

han

dlin

g, sp

ill, a

nd d

ispo

sal p

olic

ies?

☐

☐

☐

C3.

2(a)

(6) E

mpl

oyee

safe

ty –

Doe

s the

ope

ratio

n pr

ovid

e tra

inin

g an

d pr

otoc

ols f

or jo

b ha

zard

ana

lyse

s?

☐

☐

☐

C3.

2(a)

(7) E

mpl

oyee

safe

ty –

Doe

s the

ope

ratio

n pr

ovid

e tra

inin

g an

d pr

otoc

ols f

or p

erso

nal p

rote

ctiv

e eq

uipm

ent (

PPE)

pol

icie

s, in

clud

ing

resp

irato

ry p

rote

ctio

n?

☐

☐

☐

C3.

2(b)

Em

ploy

ee sa

fety

– D

oes t

he o

pera

tion

prov

ide

and

mai

ntai

n at

leas

t on

e em

erge

ncy

eye

flush

ing

stat

ion

read

ily a

cces

sibl

e to

all

empl

oyee

s and

ac

cess

to a

dequ

ate

eye

flush

ing

wat

er fo

r eac

h em

ploy

ee?

☐

☐

☐

SAMPLE

C3.

29(c

) Em

ploy

ee sa

fety

– D

oes t

he o

pera

tion

visi

bly

post

and

mai

ntai

n an

em

erge

ncy

cont

act l

ist w

hich

incl

udes

at a

min

imum

:(1) O

pera

tion

man

ager

co

ntac

ts; (

2) E

mer

genc

y re

spon

der c

onta

cts;

(3) P

oiso

n co

ntro

l con

tact

s; (4

) Fi

re d

epar

tmen

t con

tact

s; a

nd (5

) Spi

ll re

spon

se te

am c

onta

cts?

(Ind

icat

e th

e m

issi

ng e

mer

genc

y co

ntac

ts, i

f any

)

☐

☐

☐

D4.

1(a)

(1) F

acili

ties c

ompl

ianc

e –

Doe

s the

ope

ratio

n co

mpl

y w

ith a

ll le

gal

requ

irem

ents

for r

estri

ctio

ns o

n th

e si

ze o

f the

cul

tivat

ion

area

?

☐

☐

☐

D4.

1(a)

(2) F

acili

ties c

ompl

ianc

e –

Doe

s the

ope

ratio

n co

mpl

y w

ith a

ll le

gal

requ

irem

ents

for r

estri

ctio

ns o

n th

e nu

mbe

r of c

anna

bis p

lant

s allo

wed

or o

ther

qu

antit

ativ

e lim

its?

☐

☐

☐

D4.

1(a)

(3) F

acili

ties c

ompl

ianc

e –

Doe

s the

ope

ratio

n co

mpl

y w

ith a

ll le

gal

requ

irem

ents

for l

ight

pol

lutio

n re

stric

tions

? ☐

☐

☐

D4.

1(b)

(1) F

acili

ties c

ompl

ianc

e –

Is c

ultiv

atio

n op

erat

ion

loca

ted

on

prop

erty

that

is z

oned

for s

uch

use

and

loca

ted

in a

fully

per

mitt

ed, n

on-

resi

dent

ial s

truct

ure?

☐

☐

☐

D4.

1(b)

(1)(

i) Fa

cilit

ies c

ompl

ianc

e –

Is c

ultiv

atio

n op

erat

ion

cons

truct

ed in

co

mpl

ianc

e w

ith lo

cal b

uild

ing

code

s?

☐

☐

☐

D4.

1(b)

(1)(

ii) F

acili

ties c

ompl

ianc

e –

If in

door

s, do

es th

e op

erat

ion

have

a

com

plet

e ro

of e

nclo

sure

supp

orte

d by

con

nect

ing

wal

ls e

xten

ding

from

the

grou

nd to

the

roof

?

☐

☐

☐

D4.

1(b)

(1)(

iii) F

acili

ties c

ompl

ianc

e –

Is th

e op

erat

ion

secu

re a

gain

st

unau

thor

ized

ent

ry?

☐

☐

☐

D4.

1(b)

(1)(

iv) F

acili

ties c

ompl

ianc

e –

Doe

s the

ope

ratio

n m

inim

ize

unne

cess

ary

visu

al, a

udito

ry, o

r olfa

ctor

y ev

iden

ce o

f ind

oor c

anna

bis

culti

vatio

n?

☐

☐

☐

D4.

1(b)

(2) F

acili

ties c

ompl

ianc

e –

If th

ere

is a

n ou

tdoo

r cul

tivat

ion

oper

atio

n an

d/or

gre

enho

use

culti

vatio

n op

erat

ion

loca

ted

on a

pro

perty

, is i

t zon

ed fo

r ☐

☐

☐

SAMPLE

such

use

?

D4.

1(b)

(3) F

acili

ties c

ompl

ianc

e –

Is th

e ou

tdoo

r cul

tivat

ion

oper

atio

n an

d/or

gr

eenh

ouse

ope

ratio

ns lo

cate

d w

ithin

any

setb

acks

that

per

tain

to th

e pr

oper

ty?

☐

☐

☐

D4.

1(b)

(4) F

acili

ties c

ompl

ianc

e –

If th

e op

erat

ion

incl

udes

a g

reen

hous

e, is

th

e gr

eenh

ouse

cul

tivat

ion

stru

ctur

e fu

lly p

erm

itted

and

bui

lt to

cod

e?

☐

☐

☐

D4.

1(c)

(1) F

acili

ties c

ompl

ianc

e –

If th

ere

is a

pro

cess

ing

oper

atio

n, is

it

loca

ted

on a

pro

perty

that

is z

oned

for s

uch

use?

☐

☐

☐

D4.

1(c)

(2) F

acili

ties c

ompl

ianc

e –

If th

ere

is a

pro

cess

ing

oper

atio

n, is

it

loca

ted

with

in a

ny se

tbac

ks th

at p

erta

in to

the

prop

erty

whe

re th

e pr

oces

sing

is

taki

ng p

lace

?

☐

☐

☐

D4.

1(c)

(3) F

acili

ties c

ompl

ianc

e –

If th

ere

is a

pro

cess

ing

oper

atio

n, is

the

stru

ctur

e fu

lly p

erm

itted

and

con

struc

ted

in c

ompl

ianc

e w

ith lo

cal b

uild

ing

code

?

☐

☐

☐

D4.

1(d)

Fac

ilitie

s com

plia

nce

– D

oes t

he o

utdo

or c

ultiv

atio

n or

gre

enho

use

culti

vatio

n op

erat

ion

(if a

ny) s

hiel

d or

dow

ncas

t sup

plem

enta

l lig

htin

g?

☐

☐

☐

D4.

1(e)

Fac

ilitie

s com

plia

nce

– D

oes t

he o

pera

tion

trans

port

cann

abis

in a

se

cure

d en

clos

ed c

onta

iner

or s

ecur

ed tr

unk

of th

e de

liver

y ve

hicl

e?

☐

☐

☐

D4.

2(a)

Fac

ilitie

s fir

e pr

even

tion

– A

re th

e ro

oms o

f the

indo

or c

ultiv

atio

n op

erat

ion

(if a

ny) i

n w

hich

ope

ratio

nal s

uppl

emen

tal l

ight

ing,

bal

last

s, or

el

ectri

cal c

ontro

l pan

els a

re lo

cate

d co

nstru

cted

with

a m

inim

um o

f a o

ne-h

our

firew

all a

ssem

bly?

☐

☐

☐

D4.

2(b)

(1) F

acili

ties f

ire

prev

entio

n –

Doe

s the

ope

ratio

n pr

ovid

e at

leas

t on

e op

erat

ing

fire

extin

guis

her?

☐

☐

☐

D4.

2(b)

(2) F

acili

ties f

ire

prev

entio

n –

Doe

s the

ope

ratio

n pr

ovid

e ad

ditio

nal

fire

extin

guis

hers

in a

num

ber p

ropo

rtion

al to

the

wat

ts o

f sup

plem

enta

l lig

htin

g us

ed in

the

faci

lity

(one

fire

ext

ingu

ishe

r per

eve

ry 1

0,00

0 w

atts

of

☐

☐

☐

SAMPLE

light

ing)

, or i

n ac

cord

ance

with

loca

l fire

cod

e?

D4.

2(c)

(1) F

acili

ties f

ire

prev

entio

n –

Are

the

fire

extin

guis

hers

eas

ily

acce

ssib

le to

em

ploy

ees f

rom

eve

ry ro

om a

nd in

eac

h ha

llway

of t

he fa

cilit

y?

☐

☐

☐

D4.

2(c)

(2) F

acili

ties f

ire

prev

entio

n –

Are

the

fire

extin

guis

hers

mai

ntai

ned

annu

ally

or a

s oth

erw

ise

spec

ified

by

the

man

ufac

ture

r?

☐

☐

☐

D4.

2(c)

(3) F

acili

ties f

ire

prev

entio

n –

Are

the

fire

extin

guis

hers

of t

he

appr

opria

te c

lass

ratin

g fo

r the

type

of f

ire a

ssoc

iate

d w

ith th

e fu

nctio

ns b

eing

pe

rform

ed in

the

faci

lity

(e.g

., el

ectri

cal,

chem

ical

)?

☐

☐

☐

D4.

2(d)

Fac

ilitie

s fir

e pr

even

tion

– A

re fl

amm

able

pro

duct

s sto

red

in a

pr

oper

ly m

arke

d fir

e co

ntai

nmen

t cab

inet

or a

rea?

☐

☐

☐

D4.

2(e)

Fac

ilitie

s fir

e pr

even

tion

– D

oes t

he o

pera

tion

have

sign

age

that

co

mpl

ies w

ith N

atio

nal F

ire P

rote

ctio

n A

ssoc

iatio

n (N

FPA

) sta

ndar

d 70

4?

☐

☐

☐

D4.

3(a)

Fac

ilitie

s san

itatio

n –

Doe

s the

ope

ratio

n pr

ovid

e em

ploy

ees w

ith

adeq

uate

and

read

ily-a

cces

sibl

e to

ilet f

acili

ties?

☐

☐

☐

D4.

3(a)

(1) F

acili

ties s

anita

tion

– D

oes o

pera

tion

prov

ide

empl

oyee

s with

ad

equa

te a

nd re

adily

-acc

essi

ble

toile

t fac

ilitie

s tha

t are

mai

ntai

ned

in a

sa

nita

ry c

ondi

tion?

☐

☐

☐

D4.

3(a)

(2) F

acili

ties s

anita

tion

– D

oes o

pera

tion

prov

ide

empl

oyee

s with

ad

equa

te a

nd re

adily

-acc

essi

ble

toile

t fac

ilitie

s tha

t are

ade

quat

ely

stoc

ked

with

toile

t pap

er, s

oap,

and

sing

le-u

se p

aper

tow

els o

r oth

er d

ryin

g de

vice

s?

☐

☐

☐

D4.

3(a)

(3) F

acili

ties s

anita

tion

– D

oes o

pera

tion

prov

ide

empl

oyee

s with

ad

equa

te a

nd re

adily

-acc

essi

ble

toile

t fac

ilitie

s tha

t are

kep

t in

good

repa

ir at

al

l tim

es?

☐

☐

☐

D4.

3(b)

Fac

ilitie

s san

itatio

n –

Doe

s the

ope

ratio

n pr

ovid

e ad

equa

te a

nd

conv

enie

nt h

and-

was

hing

stat

ions

? ☐

☐

☐

SAMPLE

D4.

3(b)

(1) F

acili

ties s

anita

tion

– D

oes t

he o

pera

tion

prov

ide

hand

-was

hing

st

atio

ns w

ith ru

nnin

g w

ater

of s

uita

ble

tem

pera

ture

? ☐

☐

☐

D4.

3(b)

(2) F

acili

ties s

anita

tion

– D

oes t

he o

pera

tion

prov

ide

hand

-was

hing

st

atio

ns st

ocke

d w

ith e

ffect

ive

hand

-cle

anin

g or

sani

tizin

g pr

epar

atio

ns a

nd

sing

le-u

se p

aper

tow

els o

r oth

er d

ryin

g de

vice

s?

☐

☐

☐

D4.

3(b)

(3) F

acili

ties s

anita

tion

– D

oes t

he o

pera

tion

prov

ide

hand

-was

hing

st

atio

ns lo

cate

d at

poi

nts i

n th

e fa

cilit

y w

here

goo

d sa

nita

ry p

ract

ices

requ

ire

empl

oyee

s to

was

h or

sani

tize

thei

r han

ds?

☐

☐

☐

D4.

3(b)

(4) F

acili

ties s

anita

tion

– D

oes t

he o

pera

tion

prov

ide

hand

-was

hing

st

atio

ns a

t fie

ld lo

catio

ns a

s app

ropr

iate

? ☐

☐

☐

D4.

3(c)

(1) F

acili

ties s

anita

tion

– D

oes t

he o

pera

tion

impl

emen

t san

itatio

n pr

actic

es th

at a

ddre

ss re

mov

al o

f deb

ris?

☐

☐

☐

D4.

3(c)

(1) F

acili

ties s

anita

tion

– D

oes t

he o

pera

tion

impl

emen

t san

itatio

n pr

actic

es fo

r the

con

trol o

f the

gro

wth

of m

old,

mild

ew, a

nd a

lgae

in th

e cu

ltiva

tion

area

or p

roce

ssin

g ar

ea?

☐

☐

☐

D4.

3(c)

(2) F

acili

ties s

anita

tion

– D

oes t

he o

pera

tion

impl

emen

t pes

t con

trol

prac

tices

, inc

ludi

ng m

aint

enan

ce a

nd re

pair

of c

aulk

cra

cks a

nd d

rain

are

as?

☐

☐

☐

D4.

3(c)

(3) F

acili

ties s

anita

tion

– D

oes t

he o

pera

tion

impl

emen

t pra

ctic

es fo

r th

e id

entif

icat

ion

of h

oses

ded

icat

ed fo

r use

in c

ultiv

atio

n?

☐

☐

☐

D4.

3(c)

(4) F

acili

ties s

anita

tion

– D

oes t

he o

pera

tion

impl

emen

t pra

ctic

es fo

r m

aint

enan

ce a

nd c

lean

ing

of ir

rigat

ion

syst

ems?

☐

☐

☐

D4.

3(d)

Fac

ilitie

s san

itatio

n –

Doe

s the

pro

cess

ing

oper

atio

n pr

otec

t can

nabi

s fro

m c

onta

ct w

ith b

irds,

rode

nts,

inse

cts,

and

othe

r ani

mal

s and

from

exp

osur

e to

the

elem

ents

?

☐

☐

☐

D4.

4(a)

Fac

ilitie

s ele

ctri

cal –

Is th

e op

erat

ion’

s ele

ctric

al sy

stem

of s

uffic

ient

ca

paci

ty to

han

dle

the

actu

al e

lect

rical

load

and

inst

alle

d in

acc

orda

nce

with

an

☐

☐

☐

SAMPLE

appr

oved

ele

ctric

al p

erm

it?

D4.

4(b)

Fac

ilitie

s ele

ctri

cal –

Hav

e al

l ele

ctric

al w

ork

and

upgr

ades

bee

n pe

rform

ed w

ith p

rope

r per

mitt

ing?

☐

☐

☐

D4.

4(c)

Fac

ilitie

s ele

ctri

cal –

Is a

ll th

e el

ectri

cal e

quip

men

t con

nect

ed to

the

elec

trica

l sys

tem

in a

ccor

danc

e w

ith th

e eq

uipm

ent m

anuf

actu

rer’

s re

com

men

datio

ns?

☐

☐

☐

D4.

5(a)

Fac

ilitie

s ven

tilat

ion

– Is

the

oper

atio

n eq

uipp

ed w

ith a

dequ

ate

vent

ilatio

n to

mai

ntai

n pr

oper

hum

idity

and

tem

pera

ture

? ☐

☐

☐

D4.

5(b)

(1) F

acili

ties v

entil

atio

n –

Doe

s the

indo

or c

ultiv

atio

n op

erat

ion'

s m

echa

nica

lly p

rope

lled

air i

ntak

e sy

stem

use

a fi

lter c

apab

le o

f rem

ovin

g 99

.97%

of p

artic

les w

ith a

dia

met

er o

f 0.3

mic

rom

eter

s (µm

) to

cont

rol

pote

ntia

l con

tam

inat

ion

with

pat

hoge

nic

orga

nism

s?

☐

☐

☐

D4.

5(b)

(2) F

acili

ties v

entil

atio

n –

Doe

s the

indo

or c

ultiv

atio

n op

erat

ion'

s no

n-m

echa

nica

lly p

rope

lled

or p

assi

ve in

take

syst

em u

se a

gra

te a

nd fi

lter

suffi

cien

t to

redu

ce th

e in

trusio

n of

rode

nts a

nd in

sect

s?

☐

☐

☐

D4.

6(a)

Fac

ilitie

s dis

posa

l – Is

can

nabi

s was

te d

ispo

sal d

ocum

ente

d, d

one

in

a m

anne

r whi

ch p

reve

nts u

naut

horiz

ed u

se, a

nd c

ompl

iant

with

any

re

gula

tions

and

reco

mm

enda

tions

in th

e ju

risdi

ctio

n in

whi

ch it

ope

rate

s?

☐

☐

☐

D4.

6(b)

Fac

ilitie

s dis

posa

l – A

re b

ulbs

and

bal

last

s dis

pose

d of

in a

ccor

danc

e w

ith m

anuf

actu

rer’

s rec

omm

enda

tions

? ☐

☐

☐

D4.

7(a)

Fac

ilitie

s sec

urity

– Is

the

outd

oor a

nd/o

r gre

enho

use

culti

vatio

n op

erat

ion

encl

osed

by

a se

cure

per

imet

er fe

nce

at le

ast s

ix (6

) fee

t in

heig

ht

that

incl

udes

a lo

ckab

le g

ate

that

is lo

cked

and

doe

s not

vio

late

any

oth

er

ordi

nanc

e, c

ode

sect

ion

or p

rovi

sion

of la

w re

gard

ing

heig

ht a

nd lo

catio

n re

stric

tions

?

☐

☐

☐

D4.

7(b)

Fac

ilitie

s sec

urity

– D

oes t

he in

door

cul

tivat

ion

faci

lity

or p

roce

ssin

g fa

cilit

y ha

ve lo

ckin

g do

ors a

nd w

indo

ws w

hich

allo

w e

mer

genc

y in

gres

s and

☐

☐

☐

SAMPLE

egre

ss in

acc

orda

nce

with

app

licab

le re

gula

tions

?

D4.

7(c)

Fac

ilitie

s sec

urity

– D

oes t

he o

pera

tion

impl

emen

t and

com

mun

icat

e se

curit

y pr

otoc

ols t

o al

l per

sonn

el?

☐

☐

☐

D4.

7(d)

Fac

ilitie

s sec

urity

– D

oes t

he o

pera

tion

mai

ntai

n a

visi

tor l

og a

nd

have

a p

olic

y re

quiri

ng v

isito

rs to

be

acco

mpa

nied

by

an e

mpl

oyee

at a

ll tim

es?

☐

☐

☐

E5.

1(a)

Wat

er R

esou

rce

culti

vatio

n –

Is th

e op

erat

ion

follo

win

g lo

cal o

r st

ate

wat

er d

istri

ct re

gula

tions

for c

anna

bis p

rodu

ctio

n or

impl

emen

ting

a cu

ltiva

tion

wat

er m

anag

emen

t pla

n?

☐

☐

☐

E5.

1(a)

(1) W

ater

Res

ourc

e cu

ltiva

tion

– D

oes t

he c

ultiv

atio

n w

ater

m

anag

emen

t pla

n ad

dres

s ero

sion

pre

vent

ion?

☐

☐

☐

E5.

1(a)

(2) W

ater

Res

ourc

e cu

ltiva

tion

– D

oes t

he c

ultiv

atio

n w

ater

m

anag

emen

t pla

n ad

dres

s effl

uent

and

agr

icul

tura

l dis

char

ges?

☐

☐

☐

E5.

1(b)

Wat

er R

esou

rce

culti

vatio

n –

Is th

e op

erat

ion

disp

osin

g of

che

mic

al

solu

tions

in a

ccor

danc

e w

ith a

pplic

able

law

s and

regu

latio

ns?

☐

☐

☐

E5.

1(c)

Wat

er R

esou

rce

culti

vatio

n –

Is th

e ap

plic

atio

n of

nut

rient

s or

pest

icid

es th

roug

h an

irrig

atio

n sy

stem

(che

mig

atio

n) p

erfo

rmed

in a

ccor

danc

e w

ith st

ate

or lo

cal a

gric

ultu

ral r

egul

atio

ns?

☐

☐

☐

E5.

2(a)

Wat

er R

esou

rce

pota

ble

– If

the

oper

atio

n is

not

util

izin

g a

mun

icip

al so

urce

of p

otab

le w

ater

, is t

he o

pera

tion

test

ing

the

pota

ble

wat

er

supp

ly a

t lea

st tw

o tim

es p

er y

ear t

o en

sure

com

plia

nce

with

stat

e pr

imar

y dr

inki

ng w

ater

stan

dard

s?

☐

☐

☐

E5.

2(b)

Wat

er R

esou

rce

pota

ble

– A

re c

hem

ical

s, fe

rtiliz

ers,

pest

icid

es,

med

ia, a

nd o

ther

pro

duct

s sto

red

away

from

the

pota

ble

wat

er su

pply

? ☐

☐

☐

F6(a

) Rec

ordk

eepi

ng –

Doe

s the

ope

ratio

n ha

ve re

cord

s to

iden

tity

and

sour

ce a

ll ca

nnab

is p

ropa

gatio

n m

ater

ial w

ith su

ffici

ent s

peci

ficity

to e

nsur

e ☐

☐

☐

SAMPLE

that

the

mat

eria

l can

be

trace

d to

its s

ourc

e?

F6 (b

)(1)

(i-iv

) Rec

ordk

eepi

ng –

Doe

s the

ope

ratio

n m

aint

ain

plan

ting

reco

rds f

or e

ach

batc

h of

can

nabi

s tha

t inc

lude

at a

min

imum

: i) F

orm

of

cann

abis

pla

nted

(e.g

., se

ed, c

lone

, see

dlin

gs, e

tc.);

(ii)

Dat

e(s)

that

pla

ntin

g to

ok p

lace

; (iii

) Var

iety

(ies)

pla

nted

; (iv

) Siz

e of

the

culti

vatio

n ar

ea; a

nd (v

) Lo

catio

n of

the

culti

vatio

n ar

ea?

(Ind

icat

e an

y pa

ram

eter

s tha

t are

mis

sing

fro

m p

lant

ing

reco

rds)

☐

☐

☐

F6 (b

)(2)

Rec

ordk

eepi

ng p

ropa

gatio

n –

Doe

s the

ope

ratio

n m

aint

ain

prop

agat

ion

reco

rds f

or e

ach

batc

h of

can

nabi

s tha

t inc

lude

at a

min

imum

: (i)

Med

ia u

sed

and

whe

ther

the

med

ia w

as re

used

or n

ew p

rodu

ct; (

ii) D

escr

iptio

n of

all

actio

ns ta

ken

to p

reve

nt d

isea

se o

r pes

t iss

ues

or tr

eat t

he c

anna

bis f

or

them

; (iii

) Soi

l am

endm

ents

add

ed a

nd st

reng

th o

f the

app

licat

ion;

(iv)

N

utrie

nts a

dded

and

stre

ngth

of t

he a

pplic

atio

n; (v

) All

subs

tanc

es a

pplie

d to

th

e pl

ant(s

) sur

face

or u

sed

as a

fum

igan

t in

the

culti

vatio

n an

d/or

nur

sery

ar

ea; a

nd (v

i) Pr

unin

g or

oth

er p

hysi

cal t

echn

ique

(s)?

(Ind

icat

e an

y pa

ram

eter

s th

at a

re m

issi

ng fr

om p

ropa

gatio

n re

cord

s.)

☐

☐

☐

F6(b

)(3)

Rec

ordk

eepi

ng p

estic

ide

– D

oes t

he o

pera

tion

mai

ntai

n pe

stic

ide

reco

rds f

or e

ach

batc

h of

can

nabi

s tha

t inc

lude

at a

min

imum

: (i)

Pest

icid

e ch

emic

al n

ame;

(ii)

Bra

nd n

ame

and

man

ufac

ture

r nam

e; (i

ii) A

mou

nt o

f pe

stic

ide

appl

ied;

(iv)

Dat

e pe

stic

ide

appl

ied;

(v) I

dent

ifica

tion

or lo

catio

n of

pl

ants

to w

hich

pes

ticid

e w

as a

pplie

d; a

nd (v

i) N

ame

of a

pplic

ator

, if

requ

ired?

(Ind

icat

e an

y pa

ram

eter

s tha

t are

mis

sing

from

pes

ticid

e re

cord

s.)

☐

☐

☐

F6(b

)(4)

Rec

ordk

eepi

ng h

arve

st –

Doe

s the

ope

ratio

n m

aint

ain

harv

est

reco

rds f

or e

ach

batc

h of

can

nabi

s tha

t inc

lude

at a

min

imum

: (i)

Iden

tity

of

each

var

iety

har

vest

ed; (

ii) D

ate

of h

arve

st; (

iii) G

ross

wei

ght o

f the

can

nabi

s ha

rves

ted

for p

roce

ssin

g (g

ener

ally

reco

rded

afte

r dry

ing)

; (iv

) Tot

al w

eigh

t of

can

nabi

s was

te re

sulti

ng fr

om th

e ha

rves

t; an

d (v

) Net

wei

ght o

f har

vest

ed

cann

abis

(gro

ss w

eigh

t les

s was

te)?

(Ind

icat

e an

y pa

ram

eter

s tha

t are

mis

sing

fro

m h

arve

st re

cord

s.)

☐

☐

☐

F6(c

) Rec

ordk

eepi

ng p

roce

ssin

g –

Doe

s the

ope

ratio

n m

aint

ain

proc

essi

ng

reco

rds f

or e

ach

batc

h of

can

nabi

s tha

t inc

lude

at a

min

imum

: (1)

Iden

tity

of

the

varie

ty p

roce

ssed

; (2)

Suf

ficie

nt in

form

atio

n to

trac

e th

e pr

oces

sed

☐

☐

☐

SAMPLE

cann

abis

to it

s cul

tivat

ion

sour

ce; (

3) D

ate

of p

roce

ssin

g; (4

) Ini

tial w

eigh

t; an

d (5

) Tot

al w

eigh

t of a

ny p

roce

ssin

g lo

ss (b

ased

on

wet

or d

ry w

eigh

t)?

(Ind

icat

e an

y pa

ram

eter

s tha

t are

mis

sing

from

pro

cess

ing

reco

rds.

)

F6(d

) Rec

ordk

eepi

ng sa

les –

Doe

s the

ope

ratio

n m

aint

ain

sale

s rec

ords

for

each

bat

ch o

f can

nabi

s tha

t inc

lude

at a

min

imum

: (1)

Iden

tity

of th

e va

riety

di

strib

uted

; (2)

Tot

al w

eigh

t of e

ach

varie

ty d

istri

bute

d; (3

) Dat

e of

di

strib

utio

n; a

nd (4

) Ide

ntity

of t

he re

ceiv

ing

oper

atio

n? (I

ndic

ate

any

para

met

ers t

hat a

re m

issi

ng fr

om sa

les r

ecor

ds.)

☐

☐

☐

G7(

a) In

form

atio

n di

sclo

sure

– C

an th

e op

erat

ion

prov

ide

the

follo

win

g re

cord

s upo

n re

ques

t: (1

) Nut

rient

s use

d du

ring

culti

vatio

n; (2

) All

subs

tanc

es

appl

ied

to th

e pl

ant(s

) sur

face

or u

sed

as a

fum

igan

t in

the

culti

vatio

n ar

ea; (

3)

Pest

icid

es a

pplie

d du

ring

culti

vatio

n; a

nd (4

) Oth

er su

bsta

nces

use

d du

ring

culti

vatio

n th

at m

ay re

sult

in a

resi

due

on c

anna

bis?

(Ind

icat

e w

hich

pa

ram

eter

s tha

t can

not b

e pr

ovid

ed, i

f any

.)

☐

☐

☐

G7(

b) In

form

atio

n di

sclo

sure

– Is

info

rmat

ion

prov

ided

by

the

oper

atio

n ab

out t

he id

entit

y, q

ualit

y, a

nd c

ultiv

atio

n co

nditi

ons o

f can

nabi

s acc

urat

e?

☐

☐

☐

G7(

c) In

form

atio

n di

sclo

sure

– D

oes t

he o

pera

tion

disc

lose

the

exte

nt a

nd

type

of t

estin

g an

d an

alys

is c

ondu

cted

on

the

cann

abis

it p

rovi

des?

☐

☐

☐

G7(

c)(1

-3) I

nfor

mat

ion

disc

losu

re –

Doe

s the

dis

clos

ure

cont

ain

the

follo

win

g: (1

) The

type

of t

est,

anal

ysis

, or e

xam

inat

ion

used

, if a

ny, t

o de

term

ine

the

parti

cula

r stra

in o

r cul

tivar

of e

ach

batc

h of

can

nabi

s pro

vide

d;

(2) A

ny te

sts t

o de

term

ine

the

quan

titat

ive

leve

ls o

f con

tain

ed c

onsti

tuen

ts

and,

if so

, the

type

of t

estin

g us

ed; (

3) A

ny te

sts t

o de

term

ine

the

abse

nce

or

pres

ence

of s

peci

fic c

lass

es o

f pot

entia

l con

tam

inan

ts a

nd, i

f so,

the

type

of

test

ing

used

? (I

ndic

ate

whi

ch p

aram

eter

s are

mis

sing

from

the

disc

losu

re.)

☐

☐

☐

G7(

c)(3

)(i-i

ii) In

form

atio

n di

sclo

sure

– D

oes t

he d

iscl

osur

e of

con

tam

inan

t te

stin

g co

ntai

n in

form

atio

n re

gard

ing:

(i) P

estic

ides

; (ii)

Yea

sts a

nd m

olds

; an

d (ii

i) O

ther

mic

robi

olog

ical

con

tam

inan

ts?

(Ind

icat

e w

hich

par

amet

ers a

re

mis

sing

from

the

disc

losu

re re

gard

ing

cont

amin

ant t

estin

g. Is

it c

lear

whi

ch

test

s wer

e co

nduc

ted?

)

☐

☐

☐

SAMPLE

G7(

c)(4

) Inf

orm

atio

n di

sclo

sure

– D

oes t

he o

pera

tion

disc

lose

whe

ther

the

test

ing

was

con

duct

ed b

y th

e cu

ltiva

tion

or p

roce

ssin

g op

erat

ion

or b

y an

ex

tern

al la

bora

tory

?

☐

☐

☐

H8(

a) R

ecal

ls –

Doe

s the

ope

ratio

n ha

ve a

reca

ll pl

an th

at a

ddre

sses

at

min

imum

: (1)

Fac

tors

whi

ch n

eces

sita

te a

reca

ll pr

oced

ure;

(2) P

erso

nnel

re

spon

sible

for a

reca

ll; a

nd (3

) Not

ifica

tion

prot

ocol

s? (I

ndic

ate

whi

ch

para

met

ers a

re m

issi

ng, i

f any

.)

☐

☐

☐

H8(

b) R

ecal

ls –

Doe

s the

ope

ratio

n ha

ve a

est

ablis

hed

polic

y fo

r co

mm

unic

atin

g a

reca

ll of

can

nabi

s tha

t inc

lude

s: (1

) A m

echa

nism

to c

onta

ct

all c

usto

mer

s who

hav

e, o

r cou

ld h

ave,

obt

aine

d th

e ca

nnab

is fr

om th

e cu

ltiva

tion

oper

atio

n or

pro

cess

ing

oper

atio

n; (

2) In

form

atio

n on

the

retu

rn o

r de

stru

ctio

n of

any

reca

lled

prod

uct;

(3) A

mec

hani

sm to

con

tact

the

culti

vatio

n op

erat

ion;

and

(4) C

omm

unic

atio

n an

d ou

treac

h vi

a m

edia

, as n

eces

sary

and

ap

prop

riate

. (In

dica

te a

ny p

aram

eter

s tha

t mis

sing

from

the

reca

ll po

licy.

)

☐

☐

☐

H8(

c) R

ecal

ls –

Doe

s the

reca

ll pl

an in

clud

e di

spos

al o

f rec

alle

d m

ater

ials

in a

m

anne

r tha

t ens

ures

that

they

can

not b

e sa

lvag

ed a

nd w

ill n

ot b

e us

ed b

y a

com

plia

nt in

divi

dual

or a

ny o

ther

per

son?

☐

☐

☐

SAMPLE

A1.

1(a)

• Su

bjec

t ope

ratio

ns –

Exc

ept a

s pro

vide

d by

par

agra

phs (

b), (

c), a

nd

(d) o

f thi

s sec

tion,

any

per

son,

gro

up o

f per

sons

, non

-pro

fit e

ntity

, or b

usin

ess

entit

y is

subj

ect t

o th

is p

art i

f eng

aged

in m

anuf

actu

ring,

pac

kagi

ng, l

abel

ing,

or

hol

ding

ope

ratio

ns fo

r can

nabi

s or c

anna

bis-

der

ived

pro

duct

s in

the

juris

dict

ion

in w

hich

this

par

t app

lies.

☐

☐

☐

A1.

1(b)

• Su

bjec

t ope

ratio

ns –

A c

ompl

iant

indi

vidu

al w

ho m

anuf

actu

res,

pack

s, la

bels

, or h

olds

can

nabi

s or c

anna

bis-

deriv

ed p

rodu

cts i

n ac

cord

ance

w

ith lo

cal a

nd st

ate

law

for p

erso

nal u

se, o

r for

ano

ther

com

plia

nt in

divi

dual

at

no c

harg

e, is

not

subj

ect t

o th

is p

art.

☐

☐

☐

A1.

1(c)

• Su

bjec

t ope

ratio

ns -

Cul

tivat

ion

and

proc

essi

ng o

pera

tions

are

not

su

bjec

t to

this

par

t; ho

wev

er, t

his e

xem

ptio

n do

es n

ot a

pply

to a

ny o

ff-s

ite

war

ehou

se o

r sto

rage

faci

lity

that

serv

es th

e cu

ltiva

tion

or p

roce

ssin

g op

erat

ion.

☐

☐

☐

A1.

1(d)

• Su

bjec

t ope

ratio

ns -

Dis

pens

ing

oper

atio

ns a

re n

ot su

bjec

t to

this

pa

rt; h

owev

er, t

his e

xem

ptio

n do

es n

ot a

pply

to a

ny o

ff-s

ite w

areh

ouse

or

stor

age

faci

lity

that

serv

es th

e di

spen

sing

ope

ratio

n.

☐

☐

☐

SAMPLE

A1.

1(e)

• Su

bjec

t ope

ratio

ns -

Each

ope

ratio

n su

bjec

t to

this

par

t is

resp

onsib

le to

com

ply

with

onl

y th

ose

sect

ions

that

app

ly to

the

activ

ities

co

nduc

ted

by th

at o

pera

tion.

☐

☐

☐

A1.

2 • O

ther

stat

utor

y pr

ovis

ions

and

reg

ulat

ions

– Is

the

man

ufac

turin

g,

pack

agin

g, la

belin

g, a

nd h

oldi

ng o

pera

tion

pres

ently

com

plia

nt w

ith a

ll ot

her

appl

icab

le st

atut

ory

prov

isio

ns a

nd re

gula

tions

rela

ted

to th

ese

oper

atio

ns in

th

e ju

risdi

ctio

n in

whi

ch th

is p

art a

pplie

s, an

d re

late

d to

all

othe

r bus

ines

s ac

tiviti

es u

nder

take

n in

con

duct

ing

thes

e op

erat

ions

?

☐

☐

☐

B2.

1(1-

5) •A

cqui

sitio

n of

can

nabi

s and

can

nabi

s-de

rive

d pr

oduc

ts –

Doe

s th

e op

erat

ion

have

stan

dard

ized

pro

toco

ls, p

roce

dure

s, an

d re

ports

(i.e

., SO

Ps,

wor

k in

stru

ctio

ns, e

tc.)

for t

he a

cqui

sitio

n of

can

nabi

s and

can

nabi

s-de

rived

pr

oduc

ts?

☐

☐

☐

B2.

2(a)

(1-4

) •D

istr

ibut

ion

of c

anna

bis a

nd c

anna

bis-

deri

ved

prod

ucts

–

Doe

s the

ope

ratio

n ha

ve st

anda

rdiz

ed p

roto

cols

, pro

cedu

res,

and

repo

rts (i

.e.,

SOPs

, wor

k in

stru

ctio

ns, e

tc.)

for t

he d

istri

butio

n of

can

nabi

s and

can

nabi

s-de

rived

pro

duct

s to

lega

l ent

ities

as a

llow

ed in

acc

orda

nce

with

the

juris

dict

ion

of fa

cilit

y?

☐

☐

☐

B2.

2(b)

•Tra

nspo

rtat

ion

of c

anna

bis a

nd c

anna

bis-

deri

ved

prod

ucts

–

Doe

s the

ope

ratio

n ha

ve st

anda

rdiz

ed p

roto

cols

, pro

cedu

res,

and

repo

rts (i

.e.,

SOPs

, wor

k in

stru

ctio

ns, e

tc.)

for t

he tr

ansp

orta

tion

of c

anna

bis a

nd c

anna

bis-

deriv

ed p

rodu

cts i

n co

mpl

ianc

e w

ith ju

risdi

ctio

n gu

idel

ines

?

☐

☐

☐

B2.

3•A

ncill

ary

oper

atio

ns –

Doe

s the

ope

ratio

n en

gage

in p

erm

itted

anc

illar

y op

erat

ions

oth

er th

an th

e m

anuf

actu

ring,

pac

kagi

ng, l

abel

ing.

or h

oldi

ng o

f ca

nnab

is o

r can

nabi

s-de

rived

pro

duct

s?

☐

☐

☐

C3.

1(a)

(1-3

) • P

erso

nnel

trai

ning

– D

oes t

he m

anuf

actu

ring

oper

atio

n pr

ovid

e tra

inin

g an

d do

cum

enta

tion

show

ing

that

all

pers

onne

l are

trai

ned

to

perfo

rm a

ll as

sign

ed fu

nctio

ns a

nd a

pplic

able

requ

irem

ents

?

☐

☐

☐

SAMPLE

C3.

1(b)

(1) •

Per

sonn

el tr

aini

ng –

Doe

s the

man

ufac

turin

g op

erat

ion

prov

ide

train

ing

and

docu

men

tatio

n of

trai

ning

for p

erso

nnel

in th

e ar

eas o

f reg

ulat

ory

insp

ectio

n pr

epar

edne

ss a

nd la

w-e

nfor

cem

ent i

nter

actio

ns?

☐

☐

☐

C3.

1(b)

(2) P

erso

nnel

trai

ning

– D

oes t

he m

anuf

actu

ring

oper

atio

n pr

ovid

e tra

inin

g an

d th

e do

cum

enta

tion

of tr

aini

ng fo

r per

sonn

el in

the

area

s of U

.S.

fede

ral,

stat

e an

d lo

cal l

aws,

regu

latio

ns, a

nd p

olic

ies r

elat

ing

to th

e m

anuf

actu

ring

activ

ities

of t

he le

gally

ope

ratin

g en

tity?

☐

☐

☐

C3.

2(a)

(1) •

SO

Ps fo

r pe

rson

nel r

espo

nsib

ilitie

s – D

oes t

he m

anuf

actu

ring

oper

atio

n ha

ve st

anda

rdiz

ed p

roto

cols

, pro

cedu

res,

and

repo

rts fo

r the

ex

clus

ion

from

wor

k of

per

sonn

el w

ho b

y m

edic

al e

xam

inat

ion,

the

pers

on’s

ac

know

ledg

emen

t, or

supe

rvis

ory

obse

rvat

ion,

is sh

own

to h

ave

or a

ppea

rs to

ha

ve a

n ill

ness

, inf

ectio

n, o

pen

lesi

on, o

r any

oth

er a

bnor

mal

sour

ce o

f po

tent

ial m

icro

bial

con

tam

inat

ion

that

cou

ld re

sult

in th

e m

icro

bial

co

ntam

inat

ion

of c

ompo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss m

ater

ials

, ca

nnab

is, c

anna

bis-

deriv

ed p

rodu

cts,

or c

onta

ct su

rface

s, un

til th

e he

alth

co

nditi

on n

o lo

nger

exi

sts?

☐

☐

☐

C3.

2(a)

(2) •

SO

Ps fo

r pe

rson

nel r

espo

nsib

ilitie

s – D

oes t

he m

anuf

actu

ring

oper

atio

n ha

ve st

anda

rdiz

ed p

roto

cols

, pro

cedu

res,

and

repo

rts in

stru

ctin

g pe

rson

nel t

o no

tify

thei

r sup

ervi

sor(

s) if

they

hav

e or

if th

ere

is a

reas

onab

le

poss

ibili

ty th

at th

ey h

ave

a he

alth

con

ditio

n de

scrib

ed in

C3.

2(a)

(1) t

hat c

ould

re

sult

in m

icro

bial

con

tam

inat

ion

of a

ny c

ompo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss m

ater

ials

, can

nabi

s, ca

nnab

is-d

eriv

ed p

rodu

cts,

or a

ny c

onta

ct

surfa

ce(s

)?

☐

☐

☐

C3.

2(b)

(1-2

) • S

OPs

for

pers

onne

l hyg

iene

– D

oes t

he m

anuf

actu

ring

oper

atio

n ha

ve st

anda

rdiz

ed p

roto

cols

, pro

cedu

res,

and

repo

rts th

at in

clud

e th

e w

earin

g of

out

er g

arm

ents

in a

man

ner t

hat p

rote

cts a

gain

st th

e co

ntam

inat

ion

of c

ompo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss m

ater

ials

, can

nabi

s, ca

nnab

is-d

eriv

ed p

rodu

cts,

or a

ny c

onta

ct su

rface

and

mai

ntai

ning

ade

quat

e pe

rson

al c

lean

lines

s?

☐

☐

☐

SAMPLE

C3.

2(b)

(3)(

i-iii)

• SO

Ps fo

r pe

rson

nel h

ygie

ne –

Doe

s the

man

ufac

turin

g op

erat

ion

have

stan

dard

ized

pro

toco

ls, p

roce

dure

s, an

d si

gnag

e in

pla

ce

requ

iring

per

sonn

el to

thor

ough

ly w

ash

hand

s with

soap

(and

sani

tizin

g if

nece

ssar

y to

pro

tect

aga

inst

con

tam

inat

ion

with

mic

roor

gani

sms)

bef

ore

star

ting

wor

k, a

fter u

sing

the

rest

room

, and

at a

ny o

ther

tim

e w

hen

thei

r han

ds

may

hav

e be

com

e so

iled

or c

onta

min

ated

?

☐

☐

☐

C3.

2(b)

(4) •

SO

Ps fo

r pe

rson

nel h

ygie

ne –

Doe

s the

man

ufac

turin

g op

erat

ion

have

stan

dard

ized

pro

toco

ls, p

roce

dure

s, an

d re

ports

for t

he re

mov

al o

f all

unse

cure

d je

wel

ry a

nd o

ther

obj

ects

that

mig

ht fa

ll in

to c

ompo

nent

s, pa

ckag

ing

com

pone

nts,

cann

abis

, can

nabi

s-de

rived

pro

duct

s, eq

uipm

ent,

or

pack

agin

g an

d fo

r the

rem

oval

of h

and

jew

elry

that

can

not b

e ad

equa

tely

cl

eane

d du

ring

perio

ds in

whi

ch c

ompo

nent

s, pa

ckag

ing

com

pone

nts,

in-

proc

ess m

ater

ials

, can

nabi

s, or

can

nabi

s-de

rived

pro

duct

s are

man

ipul

ated

by

hand

? If

han

d je

wel

ry c

anno

t be

rem

oved

, it m

ust b

e co

vere

d by

mat

eria

l tha

t is

mai

ntai

ned

in a

n in

tact

, cle

an, a

nd sa

nita

ry c

ondi

tion

and

that

eff

ectiv

ely

prot

ects

aga

inst

the

cont

amin

atio

n of

com

pone

nts,

pack

agin

g co

mpo

nent

s, in

-pr

oces

s mat

eria

ls, c

anna

bis,

cann

abis

-der

ived

pro

duct

s, or

con

tact

surfa

ces.

☐

☐

☐

C3.

2(b)

(5) •

SO

Ps fo

r pe

rson

nel h

ygie

ne –

Doe

s the

man

ufac

turin

g op

erat

ion

have

stan

dard

ized

pro

toco

ls a

nd p

roce

dure

s for

the

mai

ntai

ning

of g

love

s use

d in

han

dlin

g co

mpo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss m

ater

ials

, ca

nnab

is, o

r can

nabi

s-de

rived

pro

duct

s in

an in

tact

, cle

an, a

nd sa

nita

ry

cond

ition

? G

love

s sho

uld

be o

f an

impe

rmea

ble

mat

eria

l.

☐

☐

☐

C3.

2(b)

(6) •

SO

Ps fo

r pe

rson

nel h

ygie

ne –

Doe

s the

man

ufac

turin

g op

erat

ion

have

stan

dard

ized

pro

toco

ls a

nd p

roce

dure

s for

the

wea

ring,

whe

re

appr

opria

te, o

f hai

r net

s, ca

ps, b

eard

cov

ers,

or o

ther

effe

ctiv

e ha

ir re

stra

ints

?

☐

☐

☐

C3.

2(b)

(7) •

SO

Ps fo

r pe

rson

nel h

ygie

ne –

Doe

s the

man

ufac

turin

g op

erat

ion

have

stan

dard

ized

pro

toco

ls a

nd p

roce

dure

s for

the

stor

age

of

clot

hing

or o

ther

per

sona

l bel

ongi

ngs i

n ar

eas w

here

it c

anno

t com

e in

to

cont

act w

ith o

r pot

entia

lly c

onta

min

ate

com

pone

nts,

pack

agin

g co

mpo

nent

s, in

-pro

cess

mat

eria

ls, c

anna

bis,

or c

anna

bis-

deriv

ed p

rodu

cts ?

☐

☐

☐

SAMPLE

C3.

2(b)

(8) •

SO

Ps fo

r pe

rson

nel h

ygie

ne –

Doe

s the

man

ufac

turin

g op

erat

ion

have

stan

dard

ized

pro

toco

ls a

nd p

roce

dure

s in

plac

e re

stric

ting

staf

f fro

m e

atin

g fo

od, c

hew

ing

gum

, drin

king

bev

erag

es, o

r usi

ng to

bacc

o pr

oduc

ts

whe

re c

ompo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss m

ater

ials

, can

nabi

s, or

ca

nnab

is-d

eriv

ed p

rodu

cts o

r any

con

tact

surfa

ces a

re e

xpos

ed o

r whe

re

cont

act s

urfa

ces a

re w

ashe

d?

☐

☐

☐

C3.

2(b)

(9) •

SO

Ps fo

r pe

rson

nel h

ygie

ne –

Doe

s the

man

ufac

turin

g op

erat

ion

have

stan

dard

ized

pro

toco

ls, p

roce

dure

s, an

d re

ports

in p

lace

ne

cess

ary

to p

rote

ct a

gain

st th

e co

ntam

inat

ion

of c

ompo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss m

ater

ials

, can

nabi

s, or

can

nabi

s-de

rived

pro

duct

s, or

an

y co

ntac

t sur

face

s with

mic

roor

gani

sms,

filth

, or a

ny o

ther

ext

rane

ous

mat

eria

ls, i

nclu

ding

per

spira

tion,

hai

r, co

smet

ics,

toba

cco,

che

mic

als,

and

med

icin

es a

pplie

d to

the

skin

?

☐

☐

☐

C3.

2(b)

(10)

• SO

Ps fo

r pe

rson

nel h

ygie

ne –

Doe

s the

man

ufac

turin

g op

erat

ion

have

stan

dard

ized

pro

toco

ls, p

roce

dure

s, an

d re

ports

in p

lace

ne

cess

ary

to m

aint

ain

the

secu

rity

of th

e ph

ysic

al p

lant

, to

prev

ent

unau

thor

ized

acc

ess t

o co

ntro

lled

acce

ss a

reas

, and

to m

aint

ain

stric

t con

trol o

f in

-pro

cess

mat

eria

ls, c

anna

bis,

cann

abis

-der

ived

pro

duct

s, an

d ca

nnab

is w

aste

?

☐

☐

☐

C3.

2(b)

(11)

• SO

Ps fo

r pe

rson

nel h

ygie

ne –

Doe

s the

man

ufac

turin

g op

erat

ion

have

stan

dard

ized

pro

toco

ls, p

roce

dure

s, an

d re

ports

in p

lace

ne

cess

ary

to c

ontro

l acc

ess t

o ar

eas o

nly

as a

utho

rized

by

supe

rvis

ory

pers

onne

l?

☐

☐

☐

C3.

3(a)

(1-2

) • P

erso

nnel

safe

ty –

Doe

s the

ope

ratio

n ha

ve p

olic

ies,

proc

edur

es, a

nd e

vide

nce

of a

dequ

ate

safe

ty tr

aini

ng fo

r per

sonn

el to

com

ply

with

per

sonn

el sa

fety

pol

icie

s, in

clud

ing

pers

onne

l acc

iden

t rep

ortin

g an

d in

vest

igat

ion

polic

ies,

as w

ell a

s fire

pre

vent

ion

and

resp

onse

pla

ns?

☐

☐

☐

C3.

3(a)

(3-4

) • P

erso

nnel

safe

ty –

Doe

s the

ope

ratio

n ha

ve p

olic

ies,

proc

edur

es, a

nd e

vide

nce

of a

dequ

ate

safe

ty tr

aini

ng fo

r per

sonn

el to

com

ply

with

requ

ired

mat

eria

ls h

andl

ing

and

haza

rd c

omm

unic

atio

ns p

olic

ies,

incl

udin

g m

aint

enan

ce o

f mat

eria

l saf

ety

data

shee

ts (M

SDS)

and

per

sona

l pr

otec

tive

equi

pmen

t pol

icie

s?

☐

☐

☐

C3.

3(b)

(1-5

) • P

erso

nnel

safe

ty –

Doe

s the

ope

ratio

n ha

ve a

n em

erge

ncy

cont

act l

ist v

isib

ly p

oste

d an

d m

aint

aine

d th

at in

clud

es c

onta

ct in

form

atio

n fo

r th

e op

erat

ion

man

ager

(s),

emer

genc

y re

spon

ders

, poi

son

cont

rol,

loca

l fire

de

partm

ent,

and

spill

resp

onse

team

(s)?

☐

☐

☐

SAMPLE

C3.

3(c)

• Pe

rson

nel s

afet

y– D

oes t

he o

pera

tion

have

evi

denc

e th

at it

ope

rate

s in

adh

eren

ce w

ith a

ll ap

plic

able

stan

dard

s of t

he fe

dera

l Occ

upat

iona

l Hea

lth

and

Safe

ty A

dmin

istra

tion,

as w

ell a

s any

app

licab

le st

ate

or lo

cal w

orke

r sa

fety

requ

irem

ents

?

☐

☐

☐

C3.

4(a-

b) •

Supe

rvis

or r

equi

rem

ents

– D

oes t

he o

pera

tion

have

evi

denc

e th

at e

ach

supe

rvis

or re

spon

sible

for t

he m

anuf

actu

ring,

pac

kagi

ng, l

abel

ing,

an

d ho

ldin

g of

can

nabi

s and

can

nabi

s-de

rived

pro

duct

s has

rece

ived

eith

er

adeq

uate

edu

catio

n, tr

aini

ng, a

nd e

xper

ienc

e, o

r any

com

bina

tion

ther

eof,

to

perfo

rm a

ssig

ned

func

tions

in su

ch a

man

ner a

s to

prov

ide

assu

ranc

e th

at th

e ca

nnab

is o

r can

nabi

s-de

rived

pro

duct

s has

the

iden

tity,

pur

ity, s

treng

th, a

nd

com

posi

tion

that

it p

urpo

rts o

r is r

epre

sent

ed to

pos

sess

?

☐

☐

☐

C3.

4(c)

• Su

perv

isor

req

uire

men

ts –

Doe

s the

ope

ratio

n ha

ve e

vide

nce

that

on

e or

mor

e su

perv

isor

s qua

lifie

d by

edu

catio

n, tr

aini

ng, o

r exp

erie

nce

are

assi

gned

to su

perv

ise

and

deve

lop

sani

tatio

n pr

oced

ures

? ☐

☐

☐

D4.

1(a)

• D

esig

n an

d co

nstr

uctio

n –

Doe

s the

ope

ratio

n ha

ve e

vide

nce

that

th

e ph

ysic

al p

lant

use

d in

the

man

ufac

turin

g, p

acka

ging

, lab

elin

g, o

r hol

ding

of

can

nabi

s or c

anna

bis-

deriv

ed p

rodu

cts i

s of s

uita

ble

size

, con

stru

ctio

n an

d de

sign

to fa

cilit

ate

mai

nten

ance

, cle

anin

g an

d/or

sani

tizin

g, a

s app

licab

le to

the

oper

atio

n?

☐

☐

☐

D4.

1(b)

• D

esig

n an

d co

nstr

uctio

n –

Doe

s the

ope

ratio

n ha

ve e

vide

nce

that

th

e ph

ysic

al p

lant

is d

esig

ned

in a

man

ner t

hat p

rovi

des a

dequ

ate

spac

e fo

r the

or

derly

pla

cem

ent o

f equ

ipm

ent a

nd m

ater

ials

to p

reve

nt m

ix-u

ps o

f co

mpo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss m

ater

ials

, can

nabi

s, or

ca

nnab

is-d

eriv

ed p

rodu

cts d

urin

g m

anuf

actu

ring,

pac

kagi

ng, l

abel

ing,

or

hold

ing?

☐

☐

☐

D4.

1(c)

(1) •

Des

ign

and

cons

truc

tion

– D

oes t

he o

pera

tion

have

evi

denc

e th

at

the

phys

ical

pla

nt w

as d

esig

ned

and

cons

truct

ed in

a m

anne

r tha

t red

uces

the

pote

ntia

l for

con

tam

inat

ion

of c

ompo

nent

s, pa

ckag

ing

com

pone

nts,

cann

abis

, ca

nnab

is-d

eriv

ed p

rodu

cts,

or c

onta

ct su

rface

s w

ith m

icro

orga

nism

s, ch

emic

als,

filth

, or o

ther

ext

rane

ous m

ater

ial,

incl

udin

g th

e co

nstru

ctio

n of

flo

ors,

wal

ls, a

nd c

eilin

gs th

at c

an b

e ad

equa

tely

cle

aned

, kep

t cle

an, a

nd in

go

od re

pair.

☐

☐

☐

SAMPLE

D4.

1(c)

(2) •

Des

ign

and

cons

truc

tion

– D

oes t

he o

pera

tion

have

evi

denc

e th

at

the

phys

ical

pla

nt w

as d

esig

ned

and

cons

truct

ed u

sing

fixtu

res,

duct

s, an

d pi

pes t

hat d

o no

t con

tam

inat

e co

mpo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss

mat

eria

ls, c

anna

bis,

or c

anna

bis-

deriv

ed p

rodu

cts o

r con

tact

surfa

ces b

y dr

ippi

ng, o

ther

leak

age,

or c

onde

nsat

ion?

☐

☐

☐

D4.

1(c)

(3) •

Des

ign

and

cons

truc

tion

– Is

the

phys

ical

pla

nt w

as d

esig

ned

and

cons

truct

ed in

such

a m

anne

r as t

o pr

ovid

e ai

sles

or w

orki

ng sp

aces

be

twee

n eq

uipm

ent a

nd w

alls

that

are

ade

quat

ely

unob

stru

cted

and

of a

dequ

ate

wid

th to

per

mit

all p

erso

ns to

per

form

thei

r dut

ies a

nd to

pro

tect

aga

inst

co

ntam

inat

ion

of c

ompo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss m

ater

ials

, ca

nnab

is o

r can

nabi

s-de

rived

pro

duct

s, or

con

tact

surfa

ces w

ith c

loth

ing

or

pers

onal

con

tact

?

☐

☐

☐

D4.

1(c)

(4) •

Des

ign

and

cons

truc

tion

– D

oes t

he o

pera

tion

have

evi

denc

e th

at

the

phys

ical

pla

nt w

as d

esig

ned

and

cons

truct

ed u

sing

safe

ty-ty

pe li

ght b

ulbs

, fix

ture

s, sk

ylig

hts,

or o

ther

gla

ss o

r gla

ss-li

ke m

ater

ials

in a

ll ar

eas t

hat a

re

susp

ende

d ov

er e

xpos

ed c

ompo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss

mat

eria

ls, o

r can

nabi

s or c

anna

bis-

deriv

ed p

rodu

cts?

Is t

he p

hysi

cal p

lant

is

othe

rwis

e co

nstru

cted

in a

man

ner t

hat w

ill p

rote

ct a

gain

st c

onta

min

atio

n of

co

mpo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss m

ater

ials

, or c

anna

bis o

r ca

nnab

is-d

eriv

ed p

rodu

cts i

n ca

se o

f bre

akag

e of

ove

rhea

d gl

ass o

r gla

ss-li

ke

mat

eria

ls?

☐

☐

☐

D4.

1(d)

• D

esig

n an

d co

nstr

uctio

n –

Doe

s the

ope

ratio

n ha

ve e

vide

nce

that

th

e ph

ysic

al p

lant

was

des

igne

d an

d co

nstru

cted

in su

ch a

man

ner a

s to

prov

ide

sepa

rate

or d

efin

ed a

reas

, or o

ther

con

trol s

yste

ms s

uch

as c

ompu

teriz

ed

inve

ntor

y co

ntro

ls o

r aut

omat

ed sy

stem

s of s

epar

atio

n, to

pre

vent

cro

ss-

cont

amin

atio

n an

d m

ix-u

ps o

f com

pone

nts,

cann

abis

, or c

anna

bis-

deriv

ed

prod

ucts

dur

ing

the

follo

win

g op

erat

ions

that

mig

ht ta

ke p

lace

in th

e ph

ysic

al

plan

t:

☐

☐

☐

(1) R

ecei

pt, i

dent

ifica

tion,

stor

age,

and

with

hold

ing

from

use

of q

uara

ntin

ed

com

pone

nts,

pack

agin

g co

mpo

nent

s, in

-pro

cess

mat

eria

ls, c

anna

bis,

or

cann

abis

-der

ived

pro

duct

pen

ding

dis

posi

tion

by q

ualit

y-co

ntro

l per

sonn

el;

☐

☐

☐

(2) S

tora

ge o

f app

rove

d co

mpo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss

mat

eria

ls, c

anna

bis,

or c

anna

bis-

deriv

ed p

rodu

cts;

☐

☐

☐

SAMPLE

(3) S

tora

ge o

f rej

ecte

d co

mpo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss

mat

eria

ls, c

anna

bis,

or c

anna

bis-

deriv

ed p

rodu

cts,

and

cann

abis

was

te p

endi

ng

retu

rn to

thei

r sup

plie

r or d

estru

ctio

n;

☐

☐

☐

(4) S

tora

ge o

f in-

proc

ess m

ater

ials

pen

ding

nor

mal

furth

er p

roce

ssin

g;

☐

☐

☐

(5) S

tora

ge o

f com

pone

nts,

pack

agin

g co

mpo

nent

s, in

-pro

cess

mat

eria

ls, a

nd

prod

ucts

pen

ding

repr

oces

sing

; ☐

☐

☐

(6) M

anuf

actu

ring

oper

atio

ns;

☐

☐

☐

(7) P

acka

ging

and

labe

ling

oper

atio

ns;

☐

☐

☐

(8) S

epar

atio

n of

the

man

ufac

turin

g, p

acka

ging

, lab

elin

g, a

nd h

oldi

ng o

f di

ffere

nt p

rodu

ct ty

pes i

nclu

ding

diff

eren

t typ

es o

f can

nabi

s or c

anna

bis-

deriv

ed p

rodu

cts a

nd o

ther

pro

duct

s han

dled

in th

e sa

me

phys

ical

pla

nt;

☐

☐

☐

(9) P

erfo

rman

ce o

f lab

orat

ory

anal

yses

and

stor

age

of la

bora

tory

supp

lies a

nd

sam

ples

, as a

pplic

able

; ☐

☐

☐

(10)

Cle

anin

g an

d sa

nita

tion

of c

onta

ct su

rface

s.

☐

☐

☐

D4.

1(e)

(1) •

Des

ign

and

cons

truc

tion/

wat

er –

Doe

s the

ope

ratio

n ha

ve

evid

ence

that

the

wat

er p

rovi

ded

is sa

fe a

nd sa

nita

ry, a

t sui

tabl

e te

mpe

ratu

res,

and

unde

r pre

ssur

e as

nee

ded,

for a

ll us

es w

here

wat

er d

oes n

ot b

ecom

e a

com

pone

nt o

f the

can

nabi

s-de

rived

pro

duct

?

☐

☐

☐

SAMPLE

D4.

1(e)

(2) •

Des

ign

and

cons

truc

tion/

wat

er –

Doe

s the

ope

ratio

n ha

ve

evid

ence

that

the

wat

er p

rovi

ded

is co

mpl

iant

with

app

licab

le st

ate

and

loca

l po

tabl

e w

ater

requ

irem

ents

and

with

oth

er re

quire

men

ts a

s nec

essa

ry to

ens

ure

the

wat

er re

quire

men

ts a

nd w

ith o

ther

requ

irem

ents

as n

eces

sary

to e

nsur

e th

e w

ater

doe

s not

con

tam

inat

e th

e ca

nnab

is-d

eriv

ed p

rodu

ct, f

or a

ll us

es w

here

su

ch w

ater

may

bec

ome

a co

mpo

nent

of t

he c

anna

bis-

deriv

ed p

rodu

ct, e

.g.,

whe

n su

ch w

ater

con

tact

s com

pone

nts,

pack

agin

g co

mpo

nent

s, in

-pro

cess

m

ater

ials

, can

nabi

s or c

anna

bis-

deriv

ed p

rodu

cts,

or a

ny c

onta

ct su

rface

?

☐

☐

☐

D4.

1(f)

• D

esig

n an

d co

nstr

uctio

n/ve

ntila

tion

– D

oes t

he o

pera

tion

have

ev

iden

ce th

at th

e he

atin

g, v

entil

atio

n, c

oolin

g, a

nd a

ir fil

tratio

n ha

s bee

n in

stal

led

and

mai

ntai

ned

in th

e ph

ysic

al p

lant

as n

eede

d to

ens

ure

the

qual

ity o

f th

e pr

oduc

t?

☐

☐

☐

D4.

1(f)

(1) •

Des

ign

and

cons

truc

tion/

vent

ilatio

n –

Doe

s the

ope

ratio

n ha

ve

SOPs

, pro

cedu

res,

and

mai

nten

ance

repo

rts fo

r all

vent

ilatio

n eq

uipm

ent s

uch

as fi

lters

, fan

s, ex

haus

ts, d

ust c

olle

ctio

ns, a

nd o

ther

air-

blow

ing

equi

pmen

t as

requ

ired

in a

ll ar

eas w

here

odo

rs, d

ust,

and

vapo

rs (i

nclu

ding

stea

m a

nd

noxi

ous f

umes

) tha

t may

con

tam

inat

e co

mpo

nent

s, pa

ckag

ing

com

pone

nts,

in-

proc

ess m

ater

ials

, can

nabi

s or c

anna

bis-

deriv

ed p

rodu

cts,

or c

onta

ct su

rface

s?

☐

☐

☐

D4.

1(f)

(2) •

Des

ign

and

cons

truc

tion/

vent

ilatio

n –

Doe

s the

ope

ratio

n ha

ve

evid

ence

that

whe

n fa

ns, c

ompr

esse

d ai

r, or

oth

er a

ir-bl

owin

g eq

uipm

ent i

s us

ed, s

uch

equi

pmen

ts is

des

igne

d, lo

cate

d, a

nd o

pera

ted

in a

man

ner t

hat

min

imiz

es th

e po

tent

ial f

or m

icro

orga

nism

s and

par

ticul

ate

mat

ter t

o co

ntam

inat

e co

mpo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss m

ater

ials

, ca

nnab

is, c

anna

bis-

deriv

ed p

rodu

cts,

or c

onta

ct su

rface

s?

☐

☐

☐

D4.

1(f)

(2) •

Des

ign

and

cons

truc

tion/

vent

ilatio

n –

Doe

s the

ope

ratio

n ha

ve

evid

ence

that

the

equi

pmen

t use

d to

con

trol t

empe

ratu

re, h

umid

ity, a

nd/o

r m

icro

orga

nism

s is p

rovi

ded

and

mai

ntai

ned

as n

eces

sary

to e

nsur

e th

e qu

ality

of

the

prod

uct?

☐

☐

☐

D4.

1(g)

(1-2

) • D

esig

n an

d co

nstr

uctio

n/pl

umbi

ng –

Doe

s the

ope

ratio

n ha

ve

evid

ence

that

the

plum

bing

in th

e ph

ysic

al p

lant

is o

f an

adeq

uate

size

and

de

sign

and

has

bee

n ad

equa

tely

inst

alle

d an

d m

aint

aine

d to

bot

h ca

rry

suffi

cien

t am

ount

s of w

ater

to re

quire

d lo

catio

ns th

roug

hout

the

plan

t and

pr

oper

ly c

onve

y se

wag

e an

d liq

uid

disp

osab

le w

aste

from

the

phys

ical

pla

nt?

☐

☐

☐

SAMPLE

D4.

1(g)

(3) •

Des

ign

and

cons

truc

tion/

plum

bing

– D

oes t

he o

pera

tion

have

ev

iden

ce th

at th

e pl

umbi

ng in

the

phys

ical

pla

nt is

of a

n ad

equa

te si

ze a

nd

desi

gn a

nd h

as b

een

adeq

uate

ly in

stal

led

and

mai

ntai

ned

to a

void

bei

ng a

so

urce

of c

onta

min

atio

n to

com

pone

nts,

pack

agin

g co

mpo

nent

s, in

-pro

cess

m

ater

ials

, can

nabi

s or c

anna

bis-

deriv

ed p

rodu

cts,

wat

er su

pplie

s, or

any

co

ntac

t sur

face

, or c

reat

ing

an u

nsan

itary

con

ditio

n?

☐

☐

☐

D4.

1(g)

(4) •

Des

ign

and

cons

truc

tion/

plum

bing

– D

oes t

he o

pera

tion

have

ev

iden

ce th

at th

e pl

umbi

ng in

the

phys

ical

pla

nt is

of a

n ad

equa

te si

ze a

nd

desi

gn a

nd h

as b

een

adeq

uate

ly in

stal

led

and

mai

ntai

ned

to p

rovi

de a

dequ

ate

floor

dra

inag

e in

all

area

s whe

re fl

oors

are

subj

ect t

o flo

odin

g-ty

pe c

lean

ing

or

whe

re n

orm

al o

pera

tions

rele

ase

or d

isch

arge

wat

er o

r oth

er li

quid

was

te o

n th

e flo

or?

☐

☐

☐

D4.

1(g)

(5) •

Des

ign

and

cons

truc

tion/

plum

bing

– D

oes t

he o

pera

tion

have

ev

iden

ce th

at th

e pl

umbi

ng in

the

phys

ical

pla

nt is

of a

n ad

equa

te si

ze a

nd

desi

gn a

nd h

as b

een

adeq

uate

ly in

stal

led

and

mai

ntai

ned

to n

o al

low

bac

kflo

w

from

, or c

ross

con

nect

ion

betw

een,

pip

ing

syst

ems t

hat d

isch

arge

was

te w

ater

or

sew

age

and

pipi

ng sy

stem

s tha

t car

ry w

ater

use

d fo

r man

ufac

turin

g ca

nnab

is-d

eriv

ed p

rodu

cts,

for c

lean

ing

cont

act s

urfa

ces,

or fo

r use

in

bath

room

s or h

and-

was

hing

faci

litie

s?

☐

☐

☐

D4.

1(h)

(1-3

) • D

esig

n an

d co

nstr

uctio

n/pl

umbi

ng –

Doe

s the

ope

ratio

n ha

ve

evid

ence

that

per

sonn

el h

as b

een

prov

ided

with

ade

quat

e, re

adily

acc

essi

ble

toile

t fac

ilitie

s tha

t are

mai

ntai

ned

in a

cle

an a

nd sa

nita

ry c

ondi

tion,

ade

quat

ely

stoc

ked

with

toile

t pap

er, s

oap,

and

sin

gle-

use

pape

r tow

els o

r oth

er d

ryin

g de

vice

s, an

d ke

pt in

goo

d re

pair

at a

ll tim

es?

☐

☐

☐

D4.

1(h)

(1-3

) • D

esig

n an

d co

nstr

uctio

n/pl

umbi

ng –

Doe

s the

ope

ratio

n ha

ve

evid

ence

that

per

sonn

el h

as b

een

prov

ided

with

ade

quat

e, re

adily

acc

essi

ble

toile

t fac

ilitie

s tha

t are

equ

ippe

d w

ith s

igna

ge a

dvis

ing

pers

onne

l of t

he

nece

ssity

of w

ashi

ng h

ands

prio

r to

retu

rnin

g to

wor

k?

☐

☐

☐

D4.

1(h)

(5) •

Des

ign

and

cons

truc

tion/

toile

t fac

ility

– D

oes t

he o

pera

tion

have

evi

denc

e th

at th

e to

ilet f

acili

ties a

re p

rohi

bite

d fro

m b

eing

use

d fo

r ac

tiviti

es th

at su

ppor

t pro

duct

ion

oper

atio

ns, s

uch

as c

lean

ing

of p

rodu

ctio

n eq

uipm

ent o

r ute

nsils

?

☐

☐

☐

SAMPLE

D4.

1(i)

• Des

ign

and

cons

truc

tion/

toile

t fac

ility

– D

oes t

he o

pera

tion

have

ev

iden

ce th

at it

has

take

n ac

tion

to p

reve

nt a

irbor

ne c

onta

min

atio

n fro

m to

ilet

faci

litie

s fro

m c

onta

ctin

g co

mpo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss

mat

eria

ls, c

anna

bis,

cann

abis

-der

ived

pro

duct

s, or

con

tact

s sou

rces

; for

ex

ampl

e, b

y pr

ovid

ing

adeq

uate

phy

sica

l sep

arat

ion

of to

ilet f

acili

ties f

rom

m

anuf

actu

ring,

pac

kagi

ng, l

abel

ing,

and

hol

ding

ope

ratio

ns, o

r by

use

of

nega

tive

air p

ress

ure

with

in th

e to

ilet f

acili

ty?

☐

☐

☐

D4.

1(j)

(1-3

) • D

esig

n an

d co

nstr

uctio

n/ha

nd w

ashi

ng –

Doe

s the

ope

ratio

n ha

ve e

vide

nce

that

it h

as p

rovi

ded

adeq

uate

and

con

veni

ent h

and-

was

hing

fa

cilit

ies t

hat p

rovi

de ru

nnin

g w

ater

of s

uita

ble

tem

pera

ture

, effe

ctiv

e ha

nd

clea

ning

and

/or s

aniti

zing

pre

para

tions

and

sin

gle-

use

pape

r tow

els o

r oth

er

dryi

ng d

evic

es, a

nd th

at a

re lo

cate

d at

poi

nts i

n th

e fa

cilit

y w

here

goo

d sa

nita

ry p

ract

ices

as r

equi

red

for p

erso

nnel

to w

ash

thei

r han

ds?

☐

☐

☐

D4.

1(j)

(4) •

Des

ign

and

cons

truc

tion/

hand

was

hing

– D

oes t

he o

pera

tion

have

evi

denc

e th

at it

has

SO

Ps p

rohi

bitin

g ha

nd-w

ashi

ng fa

cilit

ies f

rom

bei

ng

used

for a

ctiv

ities

that

supp

ort p

rodu

ctio

n op

erat

ions

, suc

h as

cle

anin

g of

pr

oduc

tion

equi

pmen

t or u

tens

ils ?

☐

☐

☐

D4.

1(k)

(1-3

) • D

esig

n an

d co

nstr

uctio

n/lig

htin

g –

Doe

s the

ope

ratio

n ha

ve

evid

ence

that

ade

quat

e lig

htin

g is

pro

vide

d in

all

area

s whe

re c

ompo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss m

ater

ials

, can

nabi

s, or

can

nabi

s-de

rived

pr

oduc

ts a

re e

xam

ined

, man

ufac

ture

d, p

acka

ged,

labe

led,

or h

eld,

as w

ell a

s w

here

con

tact

surfa

ces a

re c

lean

ed, i

n ha

nd-w

ashi

ng a

reas

, dre

ssin

g an

d lo

cker

ro

oms,

and

toile

t fac

ilitie

s?

☐

☐

☐

D4.

2(a)

(1) •

San

itatio

n re

quir

emen

ts -

Doe

s the

ope

ratio

n ha

ve e

vide

nce

that

th

e gr

ound

s of t

he p

hysi

cal p

lant

are

kep

t in

a co

nditi

on th

at p

rote

cts a

gain

st

cont

amin

atio

n of

com

pone

nts,

pack

agin

g co

mpo

nent

s, in

-pro

cess

mat

eria

ls,

cann

abis

, can

nabi

s-de

rived

pro

duct

s, or

con

tact

surfa

ces b

y pr

oper

ly st

orin

g eq

uipm

ent,

rem

ovin

g lit

ter a

nd w

aste

, and

cut

ting

wee

ds o

r gra

ss w

ithin

the

imm

edia

te v

icin

ity o

f the

phy

sica

l pla

nt so

that

it d

oes n

ot a

ttrac

t pes

ts, h

arbo

r pe

sts,

or p

rovi

de p

ests

a p

lace

for b

reed

ing?

☐

☐

☐

SAMPLE

D4.

2(a)

(2) •

San

itatio

n re

quir

emen

ts -

Doe

s the

ope

ratio

n ha

ve e

vide

nce

that

th

e gr

ound

s of t

he p

hysi

cal p

lant

are

kep

t in

a co

nditi

on th

at p

rote

cts a

gain

st

cont

amin

atio

n of

com

pone

nts,

pack

agin

g co

mpo

nent

s, in

-pro

cess

mat

eria

ls,

cann

abis

, can

nabi

s-de

rived

pro

duct

s, or

con

tact

surfa

ces b

y pr

oper

ly

mai

ntai

ning

road

s, ya

rds,

and

park

ing

lots

so th

at th

ey d

o no

t con

stitu

te a

so

urce

of c

onta

min

atio

n in

are

as w

here

com

pone

nts,

in-p

roce

ss m

ater

ials

, ca

nnab

is, c

anna

bis-

deriv

ed p

rodu

cts,

or c

onta

ct su

rface

s are

exp

osed

?

☐

☐

☐

D4.

2(a)

(3) •

San

itatio

n re

quir

emen

ts -

Doe

s the

ope

ratio

n ha

ve e

vide

nce

that

th

e gr

ound

s of t

he p

hysi

cal p

lant

are

kep

t in

a co

nditi

on th

at p

rovi

des

adeq

uate

ly d

rain

age

of a

reas

that

may

con

tribu

te to

the

cont

amin

atio

n of

co

mpo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss m

ater

ials

, can

nabi

s, ca

nnab

is-

deriv

ed p

rodu

cts,

or c

onta

ct su

rface

s by

seep

age,

filth

, or a

ny o

ther

ext

rane

ous

mat

eria

ls, o

r by

prov

idin

g a

bree

ding

pla

ce fo

r pes

ts?

☐

☐

☐

D4.

2(a)

(4) •

San

itatio

n re

quir

emen

ts -

Doe

s the

ope

ratio

n ha

ve e

vide

nce

that

th

e gr

ound

s of t

he p

hysi

cal p

lant

are

kep

t in

a co

nditi

on th

at p

rovi

des

adeq

uate

ly o

pera

ting

syst

ems f

or w

aste

trea

tmen

t and

dis

posa

l so

that

they

do

not c

onst

itute

a so

urce

of c

onta

min

atio

n in

are

as w

here

com

pone

nts,

pack

agin

g co

mpo

nent

s, in

-pro

cess

mat

eria

ls, c

anna

bis,

cann

abis

-der

ived

pro

duct

s, or

co

ntac

t sur

face

s are

exp

osed

?

☐

☐

☐

D4.

2(a)

(5) •

San

itatio

n re

quir

emen

ts -

Doe

s the

ope

ratio

n ha

ve e

vide

nce

that

if

the

grou

nds o

f the

phy

sica

l pla

nt a

re b

orde

red

by g

roun

ds n

ot u

nder

the

oper

atio

n’s c

ontro

l, an

d if

thos

e ot

her g

roun

ds a

re n

ot m

aint

aine

d n

the

man

ner

desc

ribed

in th

is se

ctio

n, c

are

has b

een

exer

cise

d in

the

plan

t by

insp

ectio

n,

exte

rmin

atio

n, o

r oth

er m

eans

to e

xclu

de p

ests

, dirt

, and

filth

or a

ny o

ther

ex

trane

ous m

ater

ials

that

may

be

a so

urce

of c

onta

min

atio

n?

☐

☐

☐

D4.

2(b)

• Sa

nita

tion

requ

irem

ents

– D

oes t

he o

pera

tion

have

evi

denc

e th

at

the

phys

ical

pla

nt is

mai

ntai

ned

in a

cle

an a

nd sa

nita

ry c

ondi

tion

and

mai

ntai

ned

in su

ffici

ent r

epai

r to

prev

ent c

ompo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss m

ater

ials

, can

nabi

s, ca

nnab

is-d

eriv

ed p

rodu

cts,

or c

onta

ct su

rface

s fro

m b

ecom

ing

cont

amin

ated

?

☐

☐

☐

D4.

2(c)

(1) •

San

itatio

n re

quir

emen

ts –

Doe

s the

ope

ratio

n ha

ve e

vide

nce

that

th

e ph

ysic

al p

lant

has

SO

Ps, p

roce

dure

s, an

d re

cord

s in

plac

e fo

r the

pro

per

stor

age,

han

dlin

g, a

nd c

ontro

l of c

lean

ing

com

poun

ds, s

aniti

zing

age

nts,

pest

icid

es, a

nd o

ther

toxi

c m

ater

ials

so a

s to

keep

the

prod

ucts

free

from

m

icro

orga

nism

s of p

ublic

hea

lth si

gnifi

canc

e?

☐

☐

☐

SAMPLE

D4.

2(c)

(2)(i

-iv) •

San

itatio

n re

quir

emen

ts –

Doe

s the

ope

ratio

n ha

ve

evid

ence

that

toxi

c m

ater

ials

are

not

use

d or

hel

d in

a p

hysi

cal p

lant

in w

hich

co

mpo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss m

ater

ials

, can

nabi

s, ca

nnab

is-

deriv

ed p

rodu

cts,

or c

onta

ct su

rface

s are

man

ufac

ture

d or

exp

osed

, unl

ess

thos

e m

ater

ials

are

nec

essa

ry to

mai

ntai

n cl

ean

and

sani

tary

con

ditio

ns, f

or u

se

in la

bora

tory

test

ing

proc

edur

es, f

or m

aint

aini

ng o

r ope

ratin

g th

e ph

ysic

al

plan

t or e

quip

men

t, or

for t

he u

se in

the

plan

t’s o

pera

tions

?

☐

☐

☐

D4.

2(c)

(3) •

San

itatio

n re

quir

emen

ts –

Doe

s the

ope

ratio

n ha

ve e

vide

nce

that

al

l cle

anin

g co

mpo

unds

, san

itizi

ng a

gent

s, pe

stic

ides

, pes

ticid

e ch

emic

als,

and

othe

r tox

ic m

ater

ials

are

pro

perly

iden

tifie

d, st

ored

, and

use

d in

a m

anne

r tha

t pr

otec

ts a

gain

st c

onta

min

atio

n of

com

pone

nts,

pack

agin

g co

mpo

nent

s, in

-pr

oces

s mat

eria

ls, c

anna

bis,

cann

abis

-der

ived

pro

duct

s, or

con

tact

surfa

ces?

☐

☐

☐

D4.

2(d)

(1) •

San

itatio

n re

quir

emen

ts –

Doe

s the

ope

ratio

n ha

ve S

OPs

, pr

oced

ures

, and

reco

rd k

eepi

ng in

pla

ce p

rovi

ding

ade

quat

e pe

st c

ontro

l pr

ohib

iting

ani

mal

s or p

ests

in a

reas

of t

he p

hysi

cal p

lant

? (G

uard

dog

s may

be

allo

wed

in so

me

area

s of t

he p

hysi

cal p

lant

if th

eir p

rese

nce

will

not

resu

lt in

co

ntam

inat

ion

of c

ompo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss m

ater

ials

, ca

nnab

is o

r can

nabi

s-de

rived

pro

duct

s, or

con

tact

surfa

ces.)

☐

☐

☐

D4.

2(d)

(2) •

San

itatio

n re

quir

emen

ts –

Doe

s the

ope

ratio

n ha

ve e

vide

nce

that

effe

ctiv

e m

easu

res h

ave

been

take

n to

exc

lude

pes

ts fr

om th

e ph

ysic

al

plan

t and

to p

rote

ct a

gain

st c

onta

min

atio

n of

com

pone

nts,

pack

agin

g co

mpo

nent

s, in

-pro

cess

mat

eria

ls, c

anna

bis o

r can

nabi

s-de

rived

pro

duct

s, an

d co

ntac

t sur

face

s on

the

prem

ises

by

pest

s?

☐

☐

☐

D4.

2(d)

(3) •

San

itatio

n re

quir

emen

ts –

Doe

s the

ope

ratio

n ha

ve S

OPs

, pr

oced

ures

, and

reco

rd k

eepi

ng in

pla

ce sh

owin

g th

at in

sect

icid

es, f

ungi

cide

s, an

d ro

dent

icid

es a

re n

ot u

sed

in o

r aro

und

the

phys

ical

pla

nt, u

nles

s the

y ar

e re

gist

ered

with

the

EPA

and

use

d in

acc

orda

nce

with

the

labe

l ins

truct

ions

, and

ef

fect

ive

prec

autio

ns a

re ta

ken

to p

rote

ct a

gain

st th

e co

ntam

inat

ion

of

com

pone

nts,

pack

agin

g co

mpo

nent

s, in

-pro

cess

mat

eria

ls, c

anna

bis o

r ca

nnab

is-d

eriv

ed p

rodu

cts,

or c

onta

ct su

rface

s?

☐

☐

☐

SAMPLE

D4.

2(e)

(1-3

) • S

anita

tion

requ

irem

ents

– D

oes t

he o

pera

tion

have

evi

denc

e th

at tr

ash

is re

gula

rly c

onve

yed,

stor

ed, a

nd d

ispo

sed

of in

ord

er to

min

imiz

e th

e de

velo

pmen

t of o

dors

, min

imiz

e th

e po

tent

ial t

o at

tract

, har

bor,

or b

ecom

e a

bree

ding

pla

ce fo

r pes

ts, p

rote

ct a

gain

st th

e co

ntam

inat

ion

of c

ompo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss m

ater

ial,

cann

abis

, can

nabi

s-de

rived

pr

oduc

ts, a

ny c

onta

ct su

rface

s, w

ater

supp

lies,

and

grou

nds s

urro

undi

ng th

e ph

ysic

al p

lant

?

☐

☐

☐

D4.

2(e)

(4) •

San

itatio

n re

quir

emen

ts –

Doe

s the

ope

ratio

n ha

ve e

vide

nce

that

tra

sh is

regu

larly

con

veye

d, st

ored

, and

dis

pose

d of

in o

rder

to c

ontro

l ha

zard

ous w

aste

to p

reve

nt th

e co

ntam

inat

ion

of c

ompo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss m

ater

ial,

cann

abis

, can

nabi

s-de

rived

pro

duct

s, an

y co

ntac

t sur

face

s?

☐

☐

☐

D4.

2(f)

(1-3

) • S

anita

tion

requ

irem

ents

– D

oes t

he m

anuf

actu

ring,

pac

kagi

ng,

labe

ling,

or h

oldi

ng o

pera

tion(

s) h

ave

SOPs

, pro

cedu

res,

and

reco

rd k

eepi

ng in

pl

ace

addr

essi

ng th

e re

spon

sibili

ty fo

r and

des

crip

tion

of th

e cl

eani

ng

sche

dule

s, m

etho

ds, e

quip

men

t, an

d m

ater

ials

to b

e us

ed in

cle

anin

g th

e gr

ound

s and

bui

ldin

gs?

☐

☐

☐

D4.

2(g)

(1-2

) • S

anita

tion

requ

irem

ents

– D

oes t

he m

anuf

actu

ring,

pa

ckag

ing,

labe

ling,

or h

oldi

ng o

pera

tion(

s) h

ave

SOPs

, pro

cedu

res,

and

reco

rd k

eepi

ng in

pla

ce fo

r use

and

stor

age

of ro

dent

icid

es, i

nsec

ticid

es,

fung

icid

es, f

umig

atin

g ag

ents

, and

cle

anin

g an

d sa

nitiz

ing

agen

ts th

at a

ddre

ss

the

prev

entio

n of

the

cont

amin

atio

n of

com

pone

nts,

pack

agin

g co

mpo

nent

s, in

-pr

oces

s mat

eria

ls, c

anna

bis,

cann

abis

-der

ived

pro

duct

s, or

con

tact

surfa

ces?

☐

☐

☐

D4.

2(h)

• Sa

nita

tion

requ

irem

ents

– D

oes t

he m

anuf

actu

ring,

pac

kagi

ng,

labe

ling,

or h

oldi

ng o

pera

tion(

s) h

ave

SOPs

, pro

cedu

res,

and

reco

rd k

eepi

ng in

pl

ace

for s

anita

tion

proc

edur

es p

erfo

rmed

by

all p

erso

nnel

dur

ing

the

ordi

nary

co

urse

of o

pera

tions

?

☐

☐

☐

D4.

2(i)(

1-2)

• Sa

nita

tion

requ

irem

ents

– D

oes t

he o

pera

tion

have

evi

denc

e th

at a

ll op

erat

ions

are

con

duct

ed in

acc

orda

nce

with

ade

quat

e sa

nita

tion

prin

cipl

es in

clud

ing

the

clea

ning

and

/or s

aniti

zing

of p

rodu

ctio

n eq

uipm

ent,

cont

aine

rs, a

nd o

ther

con

tact

surfa

ces,

cont

rolli

ng a

irbor

ne c

onta

min

atio

n as

ne

eded

whe

re c

ompo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss m

ater

ials

, pr

oduc

t, or

con

tact

surfa

ces a

re e

xpos

ed?

☐

☐

☐

SAMPLE

D4.

2(i)(

3) •

Sani

tatio

n re

quir

emen

ts –

Doe

s the

ope

ratio

n ha

ve S

OPs

, pr

oced

ures

, and

reco

rd k

eepi

ng in

pla

ce fo

r pro

per s

anita

ry h

andl

ing

proc

edur

es?

☐

☐

☐

D4.

3(a)

(1-3

) • E

quip

men

t and

ute

nsils

– D

oes t

he p

rodu

ctio

n op

erat

ion

have

ev

iden

ce o

f the

requ

ired

use

of e

quip

men

t and

ute

nsils

that

are

of a

ppro

pria

te

desi

gn, c

onst

ruct

ion,

and

wor

kman

ship

suita

ble

for t

heir

inte

nded

use

, are

abl

e to

be

adeq

uate

ly c

lean

ed a

nd p

rope

rly m

aint

aine

d, a

nd w

ill n

ot re

sult

in th

e co

ntam

inat

ion

of c

ompo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss m

ater

ials

, ca

nnab

is, c

anna

bis-

deriv

ed p

rodu

cts,

or c

onta

ct su

rface

s?

☐

☐

☐

D4.

3(b)

(1) •

Equ

ipm

ent a

nd u

tens

ils –

Doe

s the

pro

duct

ion

oper

atio

n ha

ve

evid

ence

that

all

equi

pmen

t and

ute

nsils

use

d in

the

prod

uctio

n op

erat

ion

are

inst

alle

d an

d m

aint

aine

d to

faci

litat

e cl

eani

ng o

f the

equ

ipm

ent,

uten

sils

, and

ad

jace

nt sp

aces

?

☐

☐

☐

D4.

3(b)

(2) •

Equ

ipm

ent a

nd u

tens

ils –

Doe

s the

pro

duct

ion

oper

atio

n ha

ve

evid

ence

that

all

equi

pmen

t and

ute

nsils

are

con

stru

cted

so th

at c

onta

ct

surfa

ces a

re n

onto

xic

and

corro

sion-

resi

stan

t, an

d ne

ither

reac

tive

nor

abso

rptiv

e?

☐

☐

☐

D4.

3(b)

(3) •

Equ

ipm

ent a

nd u

tens

ils –

Doe

s the

pro

duct

ion

oper

atio

n ha

ve

evid

ence

that

all

equi

pmen

t and

ute

nsils

are

des

igne

d an

d co

nstru

cted

to

with

stan

d th

e en

viro

nmen

t in

whi

ch th

ey a

re u

sed,

the

actio

n of

com

pone

nts,

in-p

roce

ss m

ater

ials

, can

nabi

s or c

anna

bis-

deriv

ed p

rodu

cts,

and,

if a

pplic

able

, cl

eani

ng c

ompo

unds

and

sani

tizin

g ag

ents

?

☐

☐

☐

D4.

3(b)

(4) •

Equ

ipm

ent a

nd u

tens

ils –

Doe

s the

pro

duct

ion

oper

atio

n ha

ve

evid

ence

that

all

equi

pmen

t and

ute

nsils

are

mai

ntai

ned

to p

rote

ct c

ompo

nent

s, in

-pro

cess

mat

eria

ls, c

anna

bis,

and

cann

abis

-der

ived

pro

duct

s fro

m b

eing

co

ntam

inat

ed b

y an

y so

urce

?

☐

☐

☐

D4.

3(c)

• E

quip

men

t and

ute

nsils

– D

oes t

he p

rodu

ctio

n op

erat

ion

have

ev

iden

ce th

at a

ll eq

uipm

ent a

nd u

tens

ils a

re d

esig

ned

and

mai

ntai

ned

to

min

imiz

e ac

cum

ulat

ion

of d

irt, f

ilth,

org

anic

mat

eria

l, pa

rticl

es o

f com

pone

nts,

in-p

roce

ss m

ater

ials

, can

nabi

s and

can

nabi

s-de

rived

pro

duct

s, or

any

oth

er

extra

neou

s mat

eria

l or c

onta

min

ants

?

☐

☐

☐

SAMPLE

D4.

3(d)

• E

quip

men

t and

ute

nsils

– D

oes t

he p

rodu

ctio

n op

erat

ion

have

ev

iden

ce th

at c

ompr

esse

d ai

r or o

ther

gas

es in

trodu

ced

mec

hani

cally

into

or

onto

a c

ompo

nent

, pac

kagi

ng c

ompo

nent

, in-

proc

ess m

ater

ial,

cann

abis

or

cann

abis

-der

ived

pro

duct

, or c

onta

ct su

rface

, or u

sed

to c

lean

any

con

tact

su

rface

has

bee

n fil

tere

d or

oth

erw

ise

treat

ed su

ch th

at th

e co

mpo

nent

, pa

ckag

ing

com

pone

nt, i

n-pr

oces

s mat

eria

l, ca

nnab

is o

r can

nabi

s-de

rived

pr

oduc

t, or

con

tact

surfa

ce is

not

con

tam

inat

ed?

☐

☐

☐

D4.

3(e)

(1,2

) • E

quip

men

t and

ute

nsils

– D

oes t

he p

rodu

ctio

n op

erat

ion

have

ev

iden

ce th

at e

ach

freez

er, r

efrig

erat

or, a

nd o

ther

col

d-st

orag

e co

mpa

rtmen

t us

ed to

hol

d co

mpo

nent

s, in

-pro

cess

mat

eria

ls, o

r can

nabi

s or c

anna

bis-

deriv

ed

prod

ucts

is e

quip

ped

with

an

indi

catin

g th

erm

omet

er, t

empe

ratu

re-m

easu

ring

devi

ce, o

r tem

pera

ture

-rec

ordi

ng d

evic

e th

at in

dica

tes a

nd re

cord

s, or

allo

ws

for r

ecor

ding

by

hand

, the

tem

pera

ture

acc

urat

ely

with

in th

e co

mpa

rtmen

t; an

d is

equ

ippe

d w

ith a

n au

tom

ated

dev

ice

for r

egul

atin

g te

mpe

ratu

re a

nd/o

r an

auto

mat

ed a

larm

syst

em to

indi

cate

a si

gnifi

cant

tem

pera

ture

cha

nge?

☐

☐

☐

D4.

3(f)

• E

quip

men

t and

ute

nsils

– D

oes t

he p

rodu

ctio

n op

erat

ion

have

ev

iden

ce th

at a

ll in

stru

men

ts o

r con

trols

use

d in

the

man

ufac

turin

g, p

acka

ging

, la

belin

g, h

oldi

ng, o

r tes

ting;

or u

sed

to m

easu

re, r

egul

ate,

or r

ecor

d co

nditi

ons

that

con

trol o

r pre

vent

the

grow

th o

f mic

roor

gani

sms o

r oth

er c

onta

min

atio

n,

are

suita

bly

accu

rate

, pre

cise

, and

ade

quat

ely

mai

ntai

ned?

☐

☐

☐

D4.

3(g)

• E

quip

men

t and

ute

nsils

– D

oes t

he o

pera

tion

have

SO

Ps,

proc

edur

es, a

nd re

cord

kee

ping

in p

lace

that

, whe

re a

ppro

pria

te, e

nsur

e th

at

inst

rum

ents

and

con

trols

use

d in

man

ufac

turin

g, p

acka

ging

, hol

ding

, or t

estin

g co

mpo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss m

ater

ials

, can

nabi

s, an

d ca

nnab

is-d

eriv

ed p

rodu

cts a

re c

alib

rate

d, in

spec

ted,

or o

ther

wis

e ve

rifie

d be

fore

firs

t use

and

at r

outin

e in

terv

als o

r as o

ther

wis

e ne

cess

ary

to e

nsur

e th

e ac

cura

cy a

nd p

reci

sion

of t

he in

strum

ent o

r con

trol,

and

that

the

resu

lting

dat

a ar

e pe

riodi

cally

revi

ewed

by

qual

ity-c

ontro

l per

sonn

el?

Are

inst

rum

ents

or

cont

rols

that

are

pas

t the

ir ca

libra

tion,

insp

ectio

n, o

r ver

ifica

tion

due

date

, or

whi

ch c

anno

t be

adju

sted

to p

rovi

de su

itabl

e ac

cura

cy a

nd p

reci

sion

, rem

oved

fro

m u

se u

ntil

they

are

repa

ired

or re

plac

ed?

☐

☐

☐

SAMPLE

D4.

3(h)

(1,2

) • E

quip

men

t and

ute

nsils

– D

oes t

he o

pera

tion

have

SO

Ps,

proc

edur

es, a

nd re

cord

kee

ping

in p

lace

that

est

ablis

h an

d us

e ap

prop

riate

co

ntro

ls fo

r aut

omat

ed, m

echa

nica

l, an

d el

ectro

nic

equi

pmen

t (in

clud

ing

softw

are

for a

com

pute

r-co

ntro

lled

proc

ess)

to e

nsur

e th

at a

ny c

hang

es to

the

equi

pmen

t are

app

rove

d by

qua

lity-

cont

rol p

erso

nnel

and

inst

itute

d on

ly b

y au

thor

ize

pers

onne

l, as

wel

l as e

nsur

e th

at th

e eq

uipm

ent f

unct

ions

in

acco

rdan

ce w

ith it

s int

ende

d us

e?

☐

☐

☐

D4.

3(i)

(1) •

Equ

ipm

ent a

nd u

tens

ils –

Doe

s the

ope

ratio

n ha

ve S

OPs

, pr

oced

ures

, and

reco

rd k

eepi

ng in

pla

ce th

at e

nsur

e al

l equ

ipm

ent a

nd u

tens

ils,

and

any

othe

r con

tact

surfa

ces u

sed

are

prop

erly

mai

ntai

ned,

cle

aned

, and

sa

nitiz

ed, a

s nec

essa

ry, i

nclu

ding

the

taki

ng a

part,

as n

eces

sary

, for

thor

ough

m

aint

enan

ce, c

lean

ing,

and

sani

tizin

g?

☐

☐

☐

D4.

3(i)

(2) •

Equ

ipm

ent a

nd u

tens

ils –

Doe

s the

ope

ratio

n ha

ve S

OPs

, pr

oced

ures

, and

reco

rd k

eepi

ng in

pla

ce th

at e

nsur

es a

ll co

ntac

t sur

face

s use

d fo

r man

ufac

turin

g, p

acka

ging

, or h

oldi

ng lo

w- m

oist

ure

com

pone

nts,

in-

proc

ess m

ater

ials

, or c

anna

bis o

r can

nabi

s-de

rived

pro

duct

s are

in a

dry

and

sa

nita

ry c

ondi

tion

whe

n in

use

? W

hen

the

surfa

ces a

re w

et-c

lean

ed, a

re th

ey

sani

tized

, whe

n ne

cess

ary,

and

thor

ough

ly d

ried

befo

re su

bseq

uent

use

?

☐

☐

☐

D4.

3(i)

(3) •

Equ

ipm

ent a

nd u

tens

ils –

Doe

s the

ope

ratio

n ha

ve S

OPs

, pr

oced

ures

, and

reco

rd k

eepi

ng in

pla

ce e

nsur

ing

that

, if w

et p

roce

ssin

g is

use

d du

ring

prod

uctio

n, a

ll co

ntac

t sur

face

s ar

e cl

eane

d an

d sa

nitiz

ed, a

s nec

essa

ry,

to p

rote

ct a

gain

st th

e in

trodu

ctio

n of

mic

roor

gani

sms i

nto

com

pone

nts,

pack

agin

g co

mpo

nent

s, in

-pro

cess

mat

eria

ls, o

r can

nabi

s or c

anna

bis-

deriv

ed

prod

ucts

?

☐

☐

☐

D4.

3(i)

(4) •

Equ

ipm

ent a

nd u

tens

ils –

Doe

s the

ope

ratio

n ha

ve S

OPs

, pr

oced

ures

, and

reco

rd k

eepi

ng in

pla

ce e

nsur

ing

that

, whe

n cl

eani

ng a

nd

sani

tizin

g is

nec

essa

ry, a

ll co

ntac

t sur

face

s are

pro

perly

cle

aned

bef

ore

use

and

afte

r any

inte

rrup

tion

durin

g w

hich

the

cont

act s

urfa

ce m

ay h

ave

beco

me

cont

amin

ated

?

☐

☐

☐

D4.

3(i)

(5) •

Equ

ipm

ent a

nd u

tens

ils –

Doe

s the

ope

ratio

n ha

ve S

OPs

, pr

oced

ures

, and

reco

rd k

eepi

ng in

pla

ce e

nsur

ing

that

, if c

onta

ct su

rface

s are

us

ed in

a c

ontin

uous

pro

duct

ion

oper

atio

n or

in c

onse

cutiv

e op

erat

ions

in

volv

ing

diffe

rent

bat

ches

of t

he sa

me

prod

uct,

the

cont

act s

urfa

ces a

re

adeq

uate

ly c

lean

ed a

nd sa

nitiz

ed, a

s nec

essa

ry?

☐

☐

☐

SAMPLE

D4.

3(i)

(6) •

Equ

ipm

ent a

nd u

tens

ils –

Doe

s the

ope

ratio

n ha

ve S

OPs

, pr

oced

ures

, and

reco

rd k

eepi

ng in

pla

ce e

nsur

ing

all s

urfa

ces t

hat d

o no

t com

e in

to d

irect

con

tact

with

com

pone

nts,

pack

agin

g co

mpo

nent

s, in

-pro

cess

m

ater

ials

, or c

anna

bis o

r can

nabi

s-de

rived

pro

duct

s are

cle

aned

as f

requ

ently

as

nec

essa

ry to

pro

tect

aga

inst

con

tam

inat

ing

com

pone

nts o

r pro

duct

s?

☐

☐

☐

D4.

3(i)

(7) •

Equ

ipm

ent a

nd u

tens

ils –

Doe

s the

ope

ratio

n ha

ve S

OPs

, pr

oced

ures

, and

reco

rd k

eepi

ng in

pla

ce e

nsur

ing

that

sing

le-s

ervi

ce a

rticl

es

(suc

h as

ute

nsils

inte

nded

for o

ne-ti

me

use,

pap

er c

ups,

and

pape

r tow

els)

are

st

ored

in a

ppro

pria

te c

onta

iner

s and

han

dled

, dis

pens

ed, u

sed,

and

dis

pose

d of

in

a m

anne

r tha

t pro

tect

s aga

inst

con

tam

inat

ion

of c

ompo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss m

ater

ials

, can

nabi

s or c

anna

bis-

deriv

ed p

rodu

cts,

or

any

cont

act s

urfa

ce?

☐

☐

☐

D4.

3(i)

(8) •

Equ

ipm

ent a

nd u

tens

ils –

Doe

s the

ope

ratio

n ha

ve S

OPs

, pr

oced

ures

, and

reco

rd k

eepi

ng in

pla

ce e

nsur

ing

that

cle

anin

g co

mpo

unds

and

sa

nitiz

ing

agen

ts a

re a

dequ

ate

for t

heir

inte

nded

use

and

safe

und

er th

eir

cond

ition

s of u

se?

☐

☐

☐

D4.

3(i)

(9) •

Equ

ipm

ent a

nd u

tens

ils –

Doe

s the

ope

ratio

n ha

ve S

OPs

, pr

oced

ures

, and

reco

rd k

eepi

ng in

pla

ce e

nsur

ing

nece

ssar

y cl

eani

ng a

nd

sani

tizin

g of

por

tabl

e eq

uipm

ent a

nd u

tens

ils th

at h

ave

cont

act s

urfa

ces a

re

stor

ed in

a lo

catio

n an

d m

anne

r tha

t pro

tect

s the

m fr

om c

onta

min

atio

n?

☐

☐

☐

D4.

3(i)

(10)

• E

quip

men

t and

ute

nsils

– D

oes t

he o

pera

tion

have

SO

Ps,

proc

edur

es, a

nd re

cord

kee

ping

in p

lace

for t

he c

alib

ratio

n, m

aint

enan

ce,

clea

ning

, and

sani

tatio

n of

equ

ipm

ent,

inst

rum

ents

, and

ute

nsils

?

☐

☐

☐

D4.

4(a)

• Se

curi

ty r

equi

rem

ents

– D

oes t

he o

pera

tion

have

SO

Ps,

proc

edur

es, a

nd re

cord

-kee

ping

pro

toco

ls e

stab

lishe

d an

d im

plem

ente

d fo

r au

thor

ized

acc

ess t

o th

e ph

ysic

al p

lant

and

any

con

trolle

d ac

cess

are

as th

erei

n?

☐

☐

☐

D4.

4(b)

• Se

curi

ty r

equi

rem

ents

– D

oes t

he o

pera

tion

have

SO

Ps,

proc

edur

es, a

nd re

cord

kee

ping

pro

toco

ls in

pla

ce re

stric

ting

acce

ss to

the

phys

ical

pla

nt a

nd c

ontro

lling

acc

ess,

as n

eces

sary

, to

curr

ent p

erso

nnel

and

co

ntra

ctor

s as a

ppro

pria

te to

thei

r job

func

tion?

☐

☐

☐

SAMPLE

D4.

4(c)

(1-5

)(d)

• Se

curi

ty r

equi

rem

ents

– D

oes t

he o

pera

tion

have

SO

Ps,

proc

edur

es, a

nd re

cord

-kee

ping

pro

toco

ls in

pla

ce p

rovi

ding

one

or m

ore

cont

rolle

d ac

cess

are

as fo

r the

stor

age

of:

La

bels

and

oth

er p

acka

ging

com

pone

nts;

C

anna

bis a

nd c

anna

bis-

deriv

ed p

rodu

ctsp

;

C

anna

bis w

aste

;

Q

uara

ntin

ed c

ompo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss

mat

eria

ls, c

anna

bis,

or c

anna

bis-

deriv

ed p

rodu

cts.

☐

☐

☐

E5.

1(a)

(1) •

Man

ufac

turi

ng p

roto

col -

Doe

s the

ope

ratio

n ha

ve S

OPs

, pr

oced

ures

, and

reco

rd-k

eepi

ng p

roto

cols

in p

lace

for e

ach

uniq

ue fo

rmul

atio

n of

can

nabi

s-de

rived

pro

duct

pro

duce

d, in

clud

ing

the

iden

tity

of th

e pr

oduc

t?

☐

☐

☐

E5.

1(a)

(2)(

i-v) •

Man

ufac

turi

ng p

roto

col -

Doe

s the

ope

ratio

n ha

ve S

OPs

, pr

otoc

ols,

and

reco

rd-k

eepi

ng p

roto

cols

in p

lace

for e

ach

form

ulat

ion

of

prod

uct,

incl

udin

g no

min

al b

atch

size

; ide

ntity

of e

ach

com

pone

nt to

be

used

in

the

batc

h; w

eigh

t or m

easu

re o

f eac

h co

mpo

nent

to b

e us

ed in

the

batc

h,

incl

udin

g th

e un

it of

mea

sure

and

a st

atem

ent o

f any

rang

e or

var

iatio

n in

w

eigh

t or m

easu

re a

nd a

stat

emen

t of a

ny in

tent

iona

l ove

rage

am

ount

of a

co

mpo

nent

; and

the

nam

e an

d am

ount

of e

ach

ingr

edie

nt th

at w

ill b

e de

clar

ed

on th

e pr

oduc

t’s la

belin

g?

☐

☐

☐

E5.

1(a)

(3) •

Man

ufac

turi

ng p

roto

col -

Doe

s the

ope

ratio

n ha

ve S

OPs

, pr

oced

ures

, and

reco

rd k

eepi

ng p

roto

cols

in p

lace

for m

aint

aini

ng a

stat

emen

t of

theo

retic

al y

ield

for e

ach

sign

ifica

nt p

roce

ss st

ep a

nd a

t the

end

of

man

ufac

ture

, inc

ludi

ng th

e ac

cept

able

max

imum

and

min

imum

per

cent

ages

of

theo

retic

al y

ield

?

☐

☐

☐

SAMPLE

E5.

1(a)

(4)(

i-vii)

• M

anuf

actu

ring

pro

toco

l - D

oes t

he o

pera

tion

have

SO

Ps,

prot

ocol

s, an

d re

cord

kee

ping

in w

ritin

g or

ava

ilabl

e fo

r cro

ss re

fere

nce

for t

he

exec

utio

n of

eac

h pr

oces

s ste

p; p

rodu

ctio

n pr

oces

s spe

cific

atio

ns p

er s

ectio

n 5.

5; m

onito

ring

of p

rodu

ctio

n pr

oces

s spe

cific

atio

ns; i

n-pr

oces

s mat

eria

l sp

ecifi

catio

n pe

r sec

tion

5.8;

in-p

roce

ss m

ater

ial s

ampl

ing,

test

ing,

and

/or

exam

inat

ion;

can

nabi

s-de

rived

pro

duct

sam

plin

g, te

stin

g, a

nd/o

r exa

min

atio

n;

and

addi

tiona

l app

licab

le p

roce

dure

s to

be fo

llow

ed, i

f any

?

☐

☐

☐

E5.

1(a)

(4)(

i-vii)

• M

anuf

actu

ring

pro

toco

l - D

oes t

he o

pera

tion

have

SO

Ps,

prot

ocol

s, an

d re

cord

kee

ping

des

crib

ing

the

prod

uctio

n pr

oces

s tha

t ens

ures

al

l can

nabi

s-de

rived

pro

duct

spec

ifica

tions

are

con

sist

ently

met

?

☐

☐

☐

E5.

2(a)

• M

anuf

actu

ring

com

pone

nt c

ontr

ol r

equi

rem

ents

- D

oes t

he

oper

atio

n ha

ve th

e re

quire

d w

ritte

n SO

Ps, p

roto

cols,

and

reco

rd k

eepi

ng in

pl

ace

desc

ribin

g, in

suffi

cien

t det

ail,

the

rece

ipt,

iden

tific

atio

n, st

orag

e,

hand

ling,

sam

plin

g, re

view

, and

app

rova

l or r

ejec

tion

of c

ompo

nent

s?

☐

☐

☐

E5.

2(b)

• M

anuf

actu

ring

com

pone

nt c

ontr

ol r

equi

rem

ents

- D

oes t

he

oper

atio

n ha

ve th

e re

quire

d w

ritte

n SO

Ps, p

roto

cols,

and

reco

rd k

eepi

ng in

pl

ace

to p

rope

rly id

entif

y ea

ch c

onta

iner

or g

roup

of c

onta

iner

s for

co

mpo

nent

s with

a d

istin

ctiv

e co

de (e

.g. l

ot o

r con

trol n

umbe

r) fo

r eac

h lo

t in

each

ship

men

t rec

eive

d th

at a

llow

s the

lot t

o be

trac

ed b

ackw

ard

to th

e su

pplie

r, th

e da

te re

ceiv

ed, a

nd th

e na

me

of th

e co

mpo

nent

; and

forw

ard

to th

e ca

nnab

is-d

eriv

ed p

rodu

ct b

atch

es m

anuf

actu

red

or d

istri

bute

d us

ing

the

lot?

Is

the

code

use

d in

reco

rdin

g th

e di

spos

ition

of e

ach

lot,

as re

quire

d?

☐

☐

☐

E5.

2(c)

(1,2

) • M

anuf

actu

ring

com

pone

nt c

ontr

ol r

equi

rem

ents

- D

oes t

he

oper

atio

n ha

ve th

e re

quire

d w

ritte

n SO

Ps, p

roto

cols,

and

reco

rd k

eepi

ng in

pl

ace

prop

erly

des

crib

ing

the

spec

ifica

tions

for e

ach

com

pone

nt, t

o th

e ex

tent

th

ey a

re n

eces

sary

to e

nsur

e th

at m

anuf

actu

red

batc

hes o

f can

nabi

s-de

rived

pr

oduc

t mee

t spe

cific

atio

ns a

s fol

low

s: re

quire

d es

tabl

ishm

ent o

f ide

ntity

sp

ecifi

catio

n fo

r the

com

pone

nt; a

nd re

quire

d sp

ecifi

catio

ns fo

r the

stre

ngth

an

d co

mpo

sitio

n of

the

com

pone

nt a

s nec

essa

ry to

ens

ure

the

stre

ngth

and

co

mpo

sitio

n of

can

nabi

s-de

rived

pro

duct

s man

ufac

ture

d w

ith th

e co

mpo

nent

?

☐

☐

☐

SAMPLE

E5.

2(c)

(3) •

Man

ufac

turi

ng c

ompo

nent

con

trol

req

uire

men

ts -

Doe

s the

op

erat

ion

have

the

requ

ired

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in

plac

e pr

oper

ly d

escr

ibin

g th

e re

quire

d sp

ecifi

catio

ns fo

r the

pur

ity o

f the

co

mpo

nent

as n

eces

sary

to e

nsur

e th

e pu

rity

of c

anna

bis-

deriv

ed p

rodu

cts

man

ufac

ture

d w

ith th

e co

mpo

nent

, inc

ludi

ng li

mits

on

thos

e ty

pes o

f co

ntam

inat

ion

that

may

adu

ltera

te o

r lea

d to

adu

ltera

tion

of c

anna

bis-

deriv

ed

prod

ucts

man

ufac

ture

d w

ith th

e co

mpo

nent

, suc

h as

filth

, ins

ect i

nfes

tatio

n,

mic

robi

olog

ical

con

tam

inat

ion,

or o

ther

con

tam

inan

ts?

☐

☐

☐

E5.

2(d)

(1) •

Man

ufac

turi

ng c

ompo

nent

con

trol

req

uire

men

ts -

Doe

s the

op

erat

ion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

ens

urin

g th

at a

ll co

mpo

nent

s rec

eive

d an

d st

ored

pen

ding

app

rova

l are

han

dled

as

follo

ws:

upo

n re

ceip

t and

bef

ore

acce

ptan

ce, e

ach

cont

aine

r or g

roup

ing

of

cont

aine

rs is

requ

ired

to b

e ex

amin

ed v

isua

lly fo

r app

ropr

iate

labe

ling

as to

co

nten

ts, c

onta

iner

dam

age

or b

roke

n se

als,

and

cont

amin

atio

n, d

eter

min

ing

whe

ther

the

cont

aine

r con

ditio

n m

ay h

ave

resu

lted

in c

onta

min

atio

n or

de

terio

ratio

n of

the

com

pone

nts?

☐

☐

☐

E5.

2(d)

(2,3

) • M

anuf

actu

ring

com

pone

nt c

ontr

ol r

equi

rem

ents

- D

oes t

he

oper

atio

n ha

ve w

ritte

n SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce e

nsur

ing

that

all

com

pone

nts r

ecei

ved

and

stor

ed p

endi

ng a

ppro

val a

re h

andl

ed a

s fo

llow

s: th

e su

pplie

rs d

ocum

enta

tion

for e

ach

ship

men

t is t

horo

ughl

y ex

amin

ed to

ens

ure

the

com

pone

nts a

re c

onsi

sten

t with

wha

t was

ord

ered

; and

th

at th

e co

mpo

nent

s are

stor

ed u

nder

qua

rant

ine

until

they

hav

e be

en sa

mpl

ed,

revi

ewed

, and

app

rove

d or

reje

cted

by

qual

ity-c

ontro

l per

sonn

el?

☐

☐

☐

E5.

2(e)

(1) •

Man

ufac

turi

ng c

ompo

nent

con

trol

req

uire

men

ts -

Doe

s the

op

erat

ion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

ens

urin

g th

at a

ll co

mpo

nent

s are

app

rove

d or

reje

cted

as f

ollo

ws:

eac

h lo

t of

com

pone

nts m

ust b

e w

ithhe

ld fr

om u

se u

ntil

the

lot h

as b

een

sam

pled

, re

view

ed, a

nd re

leas

ed fo

r use

by

qual

ity- c

ontro

l per

sonn

el?

☐

☐

☐

E5.

2(e)

(2) •

Man

ufac

turi

ng c

ompo

nent

con

trol

req

uire

men

ts -

Doe

s the

op

erat

ion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

ens

urin

g th

at a

ll co

mpo

nent

s are

det

erm

ined

to b

e in

com

plia

nce

with

est

ablis

hed

spec

ifica

tion

eith

er th

roug

h re

view

of t

he su

pplie

r’s c

ertif

icat

e of

ana

lysi

s or

othe

r doc

umen

tatio

n, o

r thr

ough

app

ropr

iate

test

and

/or e

xam

inat

ions

? A

re

any

test

s and

exa

min

atio

ns c

ondu

cted

usi

ng a

ppro

pria

te sc

ient

ifica

lly v

alid

m

etho

ds, a

s req

uire

d?

☐

☐

☐

SAMPLE

E5.

2(e)

(3) •

Man

ufac

turi

ng c

ompo

nent

con

trol

req

uire

men

ts -

Doe

s the

op

erat

ion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

ens

urin

g th

at a

ny lo

t of a

com

pone

nt th

at m

eets

its s

peci

ficat

ions

is a

ppro

ved

and

rele

ased

for u

se b

y qu

ality

-con

trol p

erso

nnel

?

☐

☐

☐

E5.

2(e)

(4) •

Man

ufac

turi

ng c

ompo

nent

con

trol

req

uire

men

ts -

Doe

s the

op

erat

ion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

ens

urin

g th

at a

ny lo

t of a

com

pone

nt th

at d

oes n

ot m

eet i

ts sp

ecifi

catio

ns is

reje

cted

by

qual

ity-c

ontro

l per

sonn

el, u

nles

s qua

lity-

cont

rol p

erso

nnel

just

ify a

nd a

ppro

ve

a tre

atm

ent,

proc

ess a

djus

tmen

t, re

proc

essi

ng, o

r oth

er d

evia

tion

that

will

re

nder

the

com

pone

nt o

r pac

kagi

ng c

ompo

nent

suita

ble

for u

se a

nd w

ill e

nsur

e th

e fin

ishe

d ca

nnab

is p

rodu

ct b

atch

es m

anuf

actu

red

with

the

affe

cted

lot w

ill

mee

t all

spec

ifica

tions

for i

dent

ity, p

urity

, stre

ngth

, and

com

posi

tion

and

will

no

t be

othe

rwis

e co

ntam

inat

ed o

r adu

ltera

ted.

☐

☐

☐

E5.

3(a)

• M

anuf

actu

ring

bat

ch r

ecor

d - D

oes t

he o

pera

tion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

doc

umen

ting

a m

anuf

actu

ring

batc

h re

cord

of e

ach

batc

h of

can

nabi

s-de

rived

pro

duct

man

ufac

ture

d?

☐

☐

☐

E5.

3(b)

(1-2

) • M

anuf

actu

ring

bat

ch r

ecor

d - D

oes t

he o

pera

tion

have

w

ritte

n SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce e

nsur

ing

that

the

man

ufac

turin

g ba

tch

num

ber i

s abl

e to

be

cros

s-re

fere

nced

or r

epro

duce

the

appr

opria

te m

anuf

actu

ring

prot

ocol

as w

ell a

s for

m a

com

plet

e re

cord

of t

he

man

ufac

turin

g an

d co

ntro

l of t

he b

atch

?

☐

☐

☐

E5.

3(c)

• M

anuf

actu

ring

bat

ch r

ecor

d- D

oes t

he o

pera

tion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

ens

urin

g th

at e

ach

batc

h is

as

sign

ed a

bat

ch, l

ot, o

r con

trol n

umbe

r allo

win

g th

e co

mpl

ete

hist

ory

of th

e pr

oduc

tion

and

dist

ribut

ion

of th

e ba

tch

to b

e de

term

ined

? Is

the

code

use

d in

re

cord

ing

the

disp

ositi

on o

f eac

h ba

tch,

as r

equi

red?

☐

☐

☐

E5.

3(d)

(1-3

) • M

anuf

actu

ring

bat

ch r

ecor

d - D

oes t

he o

pera

tion

have

w

ritte

n SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce re

quiri

ng th

e ba

tch

reco

rd

to in

clud

e, a

s app

licab

le to

the

proc

ess,

the

iden

tity

of th

e ca

nnab

is-d

eriv

ed

prod

uct;

the

batc

h, lo

t or c

ontro

l num

ber o

f the

can

nabi

s-de

rived

pro

duct

; and

th

e ba

tch

size

?

☐

☐

☐

SAMPLE

E5.

3(d)

(4)(

i-iii)

• M

anuf

actu

ring

bat

ch r

ecor

d - D

oes t

he o

pera

tion

have

w

ritte

n SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce fo

r eac

h co

mpo

nent

use

d in

pro

duct

ion

of a

bat

ch th

at in

clud

es th

e id

entit

y of

eac

h co

mpo

nent

use

d in

th

e ba

tch;

the

batc

h, lo

t, or

con

trol n

umbe

r of e

ach

com

pone

nt u

sed

in th

e ba

tch;

and

the

actu

al w

eigh

t or m

easu

re o

f eac

h ba

tch

or lo

t of c

ompo

nent

use

d in

the

batc

h, in

clud

ing

the

unit

of m

easu

re?

☐

☐

☐

E5.

3(d)

(5) •

Man

ufac

turi

ng b

atch

rec

ord

- Doe

s the

ope

ratio

n ha

ve w

ritte

n SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce n

otin

g th

e da

te(s

) on

whi

ch a

nd,

whe

re a

pplic

able

, the

tim

e(s)

at w

hich

eac

h st

ep o

f the

man

ufac

turin

g pr

oces

s w

as p

erfo

rmed

?

☐

☐

☐

E5.

3(d)

(6) •

Man

ufac

turi

ng b

atch

rec

ord

- Doe

s the

ope

ratio

n ha

ve w

ritte

n SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce n

otin

g th

e ac

tual

resu

lts o

btai

ned

durin

g m

onito

ring

of p

rodu

ctio

n pr

oces

s par

amet

ers?

☐

☐

☐

E5.

3(d)

(7) •

Man

ufac

turi

ng b

atch

rec

ord

- Doe

s the

ope

ratio

n ha

ve w

ritte

n SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce n

otin

g th

e id

entit

y of

pro

cess

ing

lines

and

maj

or e

quip

men

t use

d in

pro

duci

ng th

e ba

tch?

☐

☐

☐

E5.

3(d)

(8) •

Man

ufac

turi

ng b

atch

rec

ord

- Doe

s the

ope

ratio

n ha

ve w

ritte

n SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce n

otin

g th

e da

te a

nd, w

here

ap

plic

able

, the

tim

e of

the

mai

nten

ance

, cle

anin

g, a

nd/o

r san

itizi

ng o

f the

m

ajor

equ

ipm

ent u

sed

in p

rodu

cing

the

batc

h, o

r a c

ross

- ref

eren

ce to

reco

rds

such

as i

ndiv

idua

l equ

ipm

ent l

ogs w

here

this

info

rmat

ion

is re

cord

ed.

☐

☐

☐

E5.

3(d)

(9) •

Man

ufac

turi

ng b

atch

rec

ord

- Doe

s the

ope

ratio

n ha

ve w

ritte

n SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce n

otin

g, if

man

ufac

ture

of t

he

batc

h us

es e

quip

men

t or i

nstru

men

ts re

quiri

ng p

erio

dic

calib

ratio

n, in

spec

tion,

or

ver

ifica

tion,

the

date

and

, whe

re a

pplic

able

, the

tim

e of

the

last

cal

ibra

tion,

in

spec

tion,

or v

erifi

catio

n, o

r the

dat

e on

whi

ch su

ch is

nex

t due

; or a

cro

ss-

refe

renc

e to

reco

rds,

such

as i

ndiv

idua

l equ

ipm

ent l

ogs,

whe

re th

is in

form

atio

n is

reco

rded

?

☐

☐

☐

SAMPLE

E5.

3(d)

(10)

• M

anuf

actu

ring

bat

ch r

ecor

d - D

oes t

he o

pera

tion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

incl

udin

g a

stat

emen

t of t

he

actu

al y

ield

and

a st

atem

ent r

egar

ding

whe

ther

the

actu

al y

ield

is w

ithin

the

acce

ptab

le ra

nge

of th

e th

eore

tical

yie

ld a

s per

sect

ion

5.1(

a)(3

) afte

r eac

h si

gnifi

cant

pro

cess

step

and

at t

he e

nd o

f man

ufac

turin

g?

☐

☐

☐

E5.

3(d)

(11)

• M

anuf

actu

ring

bat

ch r

ecor

d - D

oes t

he o

pera

tion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

rega

rdin

g an

y ca

nnab

is w

aste

gen

erat

ed

durin

g th

e pr

oduc

tion

of a

bat

ch?

☐

☐

☐

E5.

3(d)

(12)

• M

anuf

actu

ring

bat

ch r

ecor

d - D

oes t

he o

pera

tion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

doc

umen

ting

any

treat

men

t, pr

oces

s ad

just

men

t, re

proc

essi

ng, o

r oth

er d

evia

tion

that

occ

urre

d du

ring

prod

uctio

n of

th

e ba

tch

?

☐

☐

☐

E5.

3(d)

(13)

• M

anuf

actu

ring

bat

ch r

ecor

d - D

oes t

he o

pera

tion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

incl

udin

g re

cord

s of t

he d

ate,

tim

e w

here

ap

plic

able

, qua

ntity

, and

per

son

resp

onsi

ble

for a

ny sa

mpl

e re

mov

ed d

urin

g or

af

ter p

rodu

ctio

n?

☐

☐

☐

E5.

3(d)

(14)

• M

anuf

actu

ring

bat

ch r

ecor

d - D

oes t

he o

pera

tion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

of t

he a

ctua

l res

ults

of a

ny te

stin

g or

ex

amin

atio

n of

in-p

roce

ss m

ater

ial o

r can

nabi

s-de

rived

pro

duct

, or a

cro

ss-

refe

renc

e to

such

resu

lts?

☐

☐

☐

E5.

3(d)

(15)

• M

anuf

actu

ring

bat

ch r

ecor

d - D

oes t

he o

pera

tion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

incl

udin

g do

cum

enta

tion

that

the

cann

abis

-der

ived

pro

duct

mee

ts it

s spe

cific

atio

ns fo

r ide

ntity

, pur

ity, s

treng

th,

and

com

posi

tion,

in a

ccor

danc

e w

ith th

e re

quire

men

ts o

f the

man

ufac

turin

g pr

otoc

ol?

☐

☐

☐

SAMPLE

E5.

3(d)

(15)

(i-vi

i) • M

anuf

actu

ring

bat

ch r

ecor

d - D

oes t

he o

pera

tion

have

w

ritte

n SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng a

dequ

ate

to re

cord

the

iden

tity

of

each

per

son

perfo

rmin

g ea

ch p

roce

ss st

ep in

pro

duct

ion

of th

e ba

tch,

incl

udin

g bu

t not

lim

ited

to:

W

eigh

ing

or m

easu

ring

each

com

pone

nt a

nd v

erify

ing

the

wei

ght o

r m

easu

re o

f eac

h co

mpo

nent

use

d in

the

batc

h pe

r sec

tion

5.4;

Add

ing

each

com

pone

nt to

the

batc

h an

d ve

rifyi

ng th

e ad

ditio

n of

ea

ch c

ompo

nent

to th

e ba

tch

per s

ectio

n 5.

4;

(ii

i) M

onito

ring

prod

uctio

n pr

oces

s par

amet

ers;

(iv) P

erfo

rmin

g an

d ve

rifyi

ng c

alcu

latio

ns o

f the

act

ual y

ield

and

any

ot

her m

athe

mat

ical

cal

cula

tions

;

Dire

ctly

ove

rsee

ing

each

stag

e of

pro

duct

ion

of th

e ba

tch;

Perfo

rmin

g an

y ot

her c

heck

s or v

erifi

catio

ns in

pro

duct

ion

of th

e ba

tch,

as n

eede

d; a

nd

R

elea

sing

the

batc

h fro

m o

ne st

age

of p

rodu

ctio

n to

the

next

.

☐

☐

☐

E5.

3(e)

• M

anuf

actu

ring

bat

ch r

ecor

d - D

oes t

he o

pera

tion

have

evi

denc

e th

at a

ll da

ta in

the

man

ufac

turin

g ba

tch

reco

rd is

reco

rded

at t

he ti

me

at w

hich

ea

ch a

ctio

n is

per

form

ed?

☐

☐

☐

E5.

3(f)

• Man

ufac

turi

ng b

atch

rec

ord

- Doe

s the

ope

ratio

n ha

ve e

vide

nce

that

the

com

plet

ed m

anuf

actu

ring

batc

h re

cord

for e

ach

batc

h ha

s bee

n re

view

ed a

nd si

gned

by

qual

ity-c

ontro

l per

sonn

el to

det

erm

ine

com

plia

nce

with

all

appl

icab

le sp

ecifi

catio

ns a

nd o

ther

requ

irem

ents

of t

he m

anuf

actu

ring

prot

ocol

bef

ore

a ba

tch

is a

ppro

ved?

☐

☐

☐

E5.

4(a)

• A

lloca

tion

and

char

ge-in

of c

ompo

nent

s - D

oes t

he o

pera

tion

have

w

ritte

n SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng fo

r the

wei

ghin

g, m

easu

ring,

and

su

bdiv

idin

g of

com

pone

nts t

o be

use

d in

a c

anna

bis-

deriv

ed p

rodu

ct b

atch

as

appr

opria

te fo

r the

bat

ch?

☐

☐

☐

E5.

4(b)

(1-4

) • A

lloca

tion

and

char

ge-in

of c

ompo

nent

s - D

oes t

he o

pera

tion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

if a

com

pone

nt is

rem

oved

fro

m th

e or

igin

al c

onta

iner

to a

noth

er id

entif

ying

the

new

con

tain

er w

ith th

e fo

llow

ing

info

rmat

ion:

Com

pone

nt id

entit

y;

B

atch

, lot

, or c

ontro

l num

ber;

W

eigh

t or m

easu

re in

the

new

con

tain

er; a

nd

B

atch

for w

hich

com

pone

nt w

as d

ispe

nsed

, inc

ludi

ng it

s ide

ntity

and

ba

tch,

lot,

or c

ontro

l num

ber.

☐

☐

☐

SAMPLE

E5.

4(c)

(1-3

) • A

lloca

tion

and

char

ge-in

of c

ompo

nent

s - D

oes t

he o

pera

tion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

ver

ifyin

g th

at e

ach

cont

aine

r of

com

pone

nt d

ispen

sed

to m

anuf

actu

ring

has b

een

exam

ined

by

a se

cond

pe

rson

or v

erifi

ed b

y au

tom

ated

equ

ipm

ent t

o as

sure

that

the

com

pone

nt w

as

rele

ased

by

qual

ity-c

ontro

l per

sonn

el; t

he w

eigh

t or m

easu

re is

cor

rect

as

stat

ed in

the

man

ufac

turin

g pr

otoc

ol; a

nd th

e co

ntai

ner(

s) a

re p

rope

rly

iden

tifie

d?

☐

☐

☐

E5.

4(d)

• A

lloca

tion

and

char

ge-in

of c

ompo

nent

s - D

oes t

he o

pera

tion

have

w

ritte

n SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng v

erify

ing

that

eac

h co

mpo

nent

has

be

en a

dded

to th

e ba

tch

by o

ne p

erso

n an

d ve

rifie

d by

a se

cond

per

son

or, i

f th

e co

mpo

nent

s are

add

ed b

y au

tom

ated

equ

ipm

ent,

verif

ied

by o

ne p

erso

n?

☐

☐

☐

E5.

5(a)

(1-4

) • P

roce

ss m

onito

ring

and

con

trol

s dur

ing

man

ufac

turi

ng –

D

oes t

he o

pera

tion

have

evi

denc

e th

at re

quire

d pr

oces

s spe

cific

atio

ns h

ave

been

est

ablis

hed

for p

rodu

ctio

n pr

oces

s par

amet

ers a

t or d

urin

g an

y po

int,

step

, or

stag

e w

here

con

trol i

s nec

essa

ry to

ens

ure

the

qual

ity o

f the

bat

ch o

f ca

nnab

is-d

eriv

ed p

rodu

ct, a

nd to

det

ect a

ny u

nant

icip

ated

occ

urre

nce

that

may

re

sult

in c

onta

min

atio

n, a

dulte

ratio

n, o

r a fa

ilure

to m

eet s

peci

ficat

ions

. Do

the

proc

ess p

aram

eter

s mon

itore

d in

clud

e th

e fo

llow

ing

as a

ppro

pria

te: t

ime;

te

mpe

ratu

re, p

ress

ure;

and

spee

d?

☐

☐

☐

E5.

5(b)

• Pr

oces

s mon

itori

ng a

nd c

ontr

ols d

urin

g m

anuf

actu

ring

– D

oes

the

oper

atio

n ha

ve e

vide

nce

that

the

prod

uctio

n pr

oces

s par

amet

ers a

re

mon

itore

d at

or d

urin

g an

y po

int,

step

, or s

tage

whe

n pr

oces

s spe

cific

atio

ns

have

bee

n es

tabl

ishe

d?

☐

☐

☐

E5.

5(c)

• Pr

oces

s m

onito

ring

and

con

trol

s dur

ing

man

ufac

turi

ng -

Doe

s th

e op

erat

ion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

do

cum

entin

g an

d ju

stify

ing

any

devi

atio

n fro

m th

e sp

ecifi

ed p

roce

ss

para

met

ers a

nd q

uara

ntin

e an

y as

soci

ated

in-p

roce

ss m

ater

ial o

r pro

duct

? A

re

any

devi

atio

ns re

view

ed a

nd a

ppro

ved

or re

ject

ed b

y qu

ality

-con

trol

pers

onne

l? D

o qu

ality

-con

trol p

erso

nnel

app

rove

such

dev

iatio

ns o

nly

afte

r de

term

inin

g th

at th

e re

sulti

ng c

anna

bis-

deriv

ed p

rodu

ct w

ill m

eet a

ll sp

ecifi

catio

ns fo

r ide

ntity

, pur

ity, s

treng

th, a

nd c

ompo

sitio

n an

d is

not

ot

herw

ise

cont

amin

ated

or a

dulte

rate

d?

☐

☐

☐

SAMPLE

E5.

5(d)

• Pr

oces

s mon

itori

ng a

nd c

ontr

ols d

urin

g m

anuf

actu

ring

- D

oes

the

oper

atio

n ha

ve w

ritte

n SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce

show

ing

that

if a

dev

iatio

n is

reje

cted

, the

resu

lting

in-p

roce

ss o

r fin

ishe

d ca

nnab

is-d

eriv

ed p

rodu

ct sh

all b

e re

ject

ed, u

nles

s qua

lity-

cont

rol p

erso

nnel

ap

prov

e a

treat

men

t, pr

oces

s adj

ustm

ent,

repr

oces

sing

, or o

ther

dev

iatio

n th

at

ensu

res t

he c

anna

bis-

der

ived

pro

duct

bat

ches

man

ufac

ture

d w

ith th

e af

fect

ed

mat

eria

l will

mee

t all

spec

ifica

tions

for i

dent

ity, p

urity

, stre

ngth

, and

co

mpo

sitio

n an

d w

ill n

ot b

e ot

herw

ise

cont

amin

ated

or a

dulte

rate

d? I

s any

su

ch tr

eatm

ent,

proc

ess a

djus

tmen

t, re

proc

essi

ng, o

r oth

er d

evia

tion

docu

men

ted,

just

ified

, and

app

rove

d by

qua

lity-

cont

rol p

erso

nnel

, as

requ

ired?

.

☐

☐

☐

E5.

5(e)

• Pr

oces

s m

onito

ring

and

con

trol

s dur

ing

man

ufac

turi

ng -

Doe

s th

e op

erat

ion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

en

surin

g th

e pr

oper

iden

tific

atio

n of

all

com

poun

ding

and

stor

age

cont

aine

rs,

proc

essi

ng li

nes,

and

maj

or e

quip

men

t use

d du

ring

the

prod

uctio

n of

a b

atch

of

cann

abis

-der

ived

pro

duct

at a

ll tim

es to

indi

cate

thei

r con

tent

s and

, whe

n ne

cess

ary,

the

phas

e of

pro

cess

ing

of th

e ba

tch?

☐

☐

☐

E5.

5(f)

• Pro

cess

mon

itori

ng a

nd c

ontr

ols d

urin

g m

anuf

actu

ring

– D

oes

the

oper

atio

n ha

ve e

vide

nce

that

ope

ratio

ns o

n on

e co

mpo

nent

, pro

duct

, or

batc

h is

, as r

equi

red,

phy

sica

lly, s

patia

lly, o

r tem

pora

lly se

para

ted

from

op

erat

ions

on

othe

r com

pone

nts,

prod

ucts

, or b

atch

es?

☐

☐

☐

SAMPLE

E5.

5(g)

(1-4

) • P

roce

ss m

onito

ring

and

con

trol

s dur

ing

man

ufac

turi

ng -

Doe

s the

ope

ratio

n ha

ve w

ritte

n SO

Ps, p

roto

cols,

and

reco

rd k

eepi

ng in

pla

ce

ensu

ring

that

all

nece

ssar

y pr

ecau

tions

hav

e be

en ta

ken

durin

g th

e m

anuf

actu

re

of a

can

nabi

s-de

rived

pro

duct

s to

prev

ent c

onta

min

atio

n of

com

pone

nts a

nd

prod

ucts

? Th

ese

prec

autio

ns in

clud

e, b

ut a

re n

ot li

mite

d to

:

Was

hing

or c

lean

ing

com

pone

nts t

hat c

onta

in so

il or

oth

er

cont

amin

ants

;

Hol

ding

com

pone

nts,

in-p

roce

ss m

ater

ials

, and

can

nabi

s or c

anna

bis-

deriv

ed p

rodu

cts a

ppro

pria

tely

;

Prev

entin

g cr

oss-

cont

amin

atio

n an

d m

ix-u

ps b

etw

een

cont

amin

ated

co

mpo

nent

s, in

-pro

cess

mat

eria

ls, a

nd c

anna

bis o

r can

nabi

s-de

rived

pr

oduc

ts a

nd u

ncon

tam

inat

ed it

ems

U

sing

effe

ctiv

e m

easu

res t

o pr

otec

t aga

inst

the

incl

usio

n of

met

al o

r ot

her f

orei

gn m

ater

ial i

n co

mpo

nent

s or c

anna

bis p

rodu

cts,

by, f

or

exam

ple:

◦

Filte

rs, s

train

ers,

or si

eves

; ◦

Trap

s;

◦ M

agne

ts;

◦ El

ectro

nic

met

al d

etec

tors

.

☐

☐

☐

E5.

6(a)

• M

anuf

actu

ring

sam

plin

g re

quir

emen

ts -

Doe

s the

ope

ratio

n ha

ve

evid

ence

that

a re

pres

enta

tive

sam

ple

of e

ach

batc

h or

lot o

f com

pone

nt,

cann

abis

, or c

anna

bis-

deriv

ed p

rodu

ct h

as b

een

colle

cted

by

rem

ovin

g an

d co

mpo

sitin

g po

rtion

s of m

ater

ial o

r uni

ts fr

om th

roug

hout

the

cont

aine

rs in

the

batc

h or

lot?

☐

☐

☐

E5.

6(b)

• M

anuf

actu

ring

sam

plin

g re

quir

emen

ts –

Doe

s the

ope

ratio

n ha

ve

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

ens

urin

g th

at, i

f add

ition

al

repr

esen

tativ

e sa

mpl

es o

r oth

er sa

mpl

es a

re ta

ken

as a

ppro

pria

te, t

he fo

llow

ing

take

s pla

ce?

M

onito

ring

of th

e qu

ality

of i

n-pr

oces

s mat

eria

ls d

urin

g pr

oduc

tion;

Exam

inat

ion

of th

e de

gree

of v

aria

bilit

y of

mat

eria

ls o

r pro

duct

s; an

d

Inve

stig

atio

n of

kno

wn

or su

spec

ted

non-

conf

orm

ance

s.

☐

☐

☐

SAMPLE

E5.

6(c)

(1-4

) • M

anuf

actu

ring

sam

plin

g re

quir

emen

ts -

Doe

s the

ope

ratio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

doc

umen

ting

the

num

ber o

f co

ntai

ners

and

the

amou

nt o

f mat

eria

l or u

nits

to b

e re

mov

ed fr

om e

ach

cont

aine

r bas

ed o

n ap

prop

riate

crit

eria

, suc

h as

:

Qua

ntity

nee

ded

for t

estin

g, e

xam

inat

ion,

and

rese

rve;

Past

qua

lity

hist

ory

of th

e ite

m;

Ex

pect

ed v

aria

bilit

y of

the

mat

eria

l or u

nits

bei

ng sa

mpl

ed; a

nd

D

egre

e of

con

fiden

ce a

nd p

reci

sion

requ

ired?

☐

☐

☐

E5.

6(d)

• M

anuf

actu

ring

sam

plin

g re

quir

emen

ts -

Doe

s the

ope

ratio

n ha

ve

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

ens

urin

g th

at th

e co

ntai

ners

se

lect

ed fo

r sam

plin

g ha

ve b

een

base

d on

ratio

nal c

riter

ia su

ch a

s ran

dom

sa

mpl

ing

or d

irect

ed sa

mpl

ing,

as a

ppro

pria

te?

E5.

6(e)

• M

anuf

actu

ring

sam

plin

g re

quir

emen

ts -

Doe

s the

ope

ratio

n ha

ve

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

ens

urin

g th

at sa

mpl

es a

re

colle

cted

in a

ccor

danc

e w

ith th

e fo

llow

ing

proc

edur

es?

Th

e co

ntai

ners

sele

cted

for s

ampl

ing

have

bee

n cl

eane

d w

hen

nece

ssar

y in

a m

anne

r to

prev

ent i

ntro

duct

ion

of c

onta

min

ants

into

th

e co

mpo

nent

, in-

pro

cess

mat

eria

l, ca

nnab

is o

r can

nabi

s-de

rived

pr

oduc

t.

Th

e co

ntai

ners

hav

e be

en o

pene

d, sa

mpl

ed, a

nd re

seal

ed in

a m

anne

r de

sign

ed to

pre

vent

con

tam

inat

ion

of th

eir c

onte

nts a

nd

cont

amin

atio

n of

oth

er c

ompo

nent

s, in

-pro

cess

mat

eria

ls, c

anna

bis,

or c

anna

bis-

deriv

ed p

rodu

ct.

St

erile

equ

ipm

ent a

nd a

sept

ic sa

mpl

ing

tech

niqu

es h

ave

been

use

d w

hen

nece

ssar

y.

W

here

app

ropr

iate

for t

he p

urpo

se o

f the

sam

ple

and

the

natu

re o

f th

e m

ater

ial b

eing

sam

pled

, sam

ple

porti

ons a

re re

mov

ed fr

om th

e to

p, m

iddl

e, a

nd b

otto

m o

f con

tain

ers.

Such

sam

ple

porti

ons m

ay b

e co

mpo

site

d in

form

ing

the

repr

esen

tativ

e sa

mpl

e or

may

be

test

ed

sepa

rate

ly, a

s app

ropr

iate

to th

e pu

rpos

e.

C

onta

iner

s fro

m w

hich

sam

ples

hav

e be

en ta

ken

mus

t be

mar

ked

to

indi

cate

that

sam

ples

hav

e be

en re

mov

ed fr

om th

em.

SAMPLE

E5.

6(f)

• Man

ufac

turi

ng sa

mpl

ing

requ

irem

ents

– D

oes t

he o

pera

tion

have

ev

iden

ce th

at a

ll sa

mpl

e co

ntai

ners

are

iden

tifie

d w

ith th

e fo

llow

ing

info

rmat

ion?

Nam

e of

the

item

sam

pled

;

Bat

ch, l

ot, o

r con

trol n

umbe

r of t

he it

em sa

mpl

ed;

C

onta

iner

from

whi

ch th

e sa

mpl

e w

as ta

ken,

or f

or sa

mpl

es

take

n di

rect

ly fo

r the

pro

duct

ion

line,

the

equi

pmen

t lin

e an

d tim

e at

whi

ch th

e sa

mpl

e w

as ta

ken,

unl

ess s

uch

info

rmat

ion

is

docu

men

ted

sepa

rate

ly;

D

ate

on w

hich

the

sam

ple

was

take

n;

N

ame

of th

e pe

rson

who

col

lect

ed th

e sa

mpl

e; a

nd

Q

uant

ity a

nd u

nit o

f mea

sure

of t

he sa

mpl

e.

E5.

6(g)

• M

anuf

actu

ring

sam

plin

g re

quir

emen

ts –

Doe

s the

ope

ratio

n ha

ve

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

ens

urin

g th

at e

ach

sam

ple

rem

oved

from

a b

atch

or l

ot is

reco

rded

in th

e in

vent

ory

or m

anuf

actu

ring

batc

h re

cord

for t

he b

atch

or l

ot?

☐

☐

☐

E5.

6(h)

• M

anuf

actu

ring

sam

plin

g re

quir

emen

ts -

Doe

s the

ope

ratio

n ha

ve

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

ens

urin

g th

at th

e qu

antit

y of

sa

mpl

e us

ed fo

r eac

h te

st o

r exa

min

atio

n is

of s

uffic

ient

size

or n

umbe

r to

ensu

re th

e re

sults

are

repr

esen

tativ

e of

the

batc

h or

lot?

☐

☐

☐

E5.

6(i)

• Man

ufac

turi

ng sa

mpl

ing

requ

irem

ents

- D

oes t

he o

pera

tion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce e

nsur

ing

that

a re

serv

e sa

mpl

e ha

s bee

n pr

epar

ed fr

om th

e re

pres

enta

tive

sam

ple

of e

ach

batc

h or

lot o

f she

lf-st

able

com

pone

nt, c

anna

bis,

or c

anna

bis-

deriv

ed p

rodu

ct?

☐

☐

☐

E5.

6(j)

• Man

ufac

turi

ng sa

mpl

ing

requ

irem

ents

- D

oes t

he o

pera

tion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng to

ens

ure

that

all

rese

rve

sam

ples

con

sist

of

at l

east

twic

e th

e qu

antit

y ne

cess

ary

for t

ests

and

exa

min

atio

ns to

det

erm

ine

whe

ther

the

shel

f-st

able

com

pone

nt, c

anna

bis,

or c

anna

bis-

deriv

ed p

rodu

ct

mee

ts e

stab

lishe

d cr

itica

l qua

lity

spec

ifica

tions

? W

here

stat

e la

w li

mits

the

amou

nt o

f can

nabi

s and

can

nabi

s-de

rived

pro

duct

per

mitt

ed to

be

kept

on

hand

, ope

ratio

ns m

ay k

eep

smal

ler a

mou

nts i

n re

serv

e, a

s nec

essa

ry.

☐

☐

☐

E5.

6(k)

(1) •

Man

ufac

turi

ng sa

mpl

ing

requ

irem

ents

- D

oes t

he o

pera

tion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng to

ens

ure

that

rese

rve

sam

ples

of

shel

f-sta

ble

com

pone

nts a

re st

ored

usin

g an

app

ropr

iate

con

tain

er-c

losu

re to

pr

otec

t aga

inst

con

tam

inat

ion

or d

eter

iora

tion

durin

g st

orag

e?

☐

☐

☐

SAMPLE

E5.

6(k)

(2) •

Man

ufac

turi

ng sa

mpl

ing

requ

irem

ents

- D

oes t

he o

pera

tion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng to

ens

ure

that

rese

rve

sam

ples

of

shel

f-sta

ble

com

pone

nts a

re st

ored

und

er c

ondi

tions

con

sist

ent w

ith th

e co

nditi

ons u

nder

whi

ch th

e co

mpo

nent

is st

ored

at t

he m

anuf

actu

ring

oper

atio

n?

☐

☐

☐

E5.

6(k)

(3) •

Man

ufac

turi

ng sa

mpl

ing

requ

irem

ents

- D

oes t

he o

pera

tion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng to

ens

ure

that

rese

rve

sam

ples

of

shel

f-sta

ble

com

pone

nts a

re re

tain

ed fo

r one

yea

r pas

t the

exp

iratio

n da

te o

f th

e la

st b

atch

of c

anna

bis-

der

ived

pro

duct

man

ufac

ture

d fro

m th

e lo

t? W

here

st

ate

law

lim

its th

e am

ount

of c

anna

bis a

nd c

anna

bis-

deriv

ed p

rodu

ct

perm

itted

are

kep

t on

hand

, ope

ratio

ns m

ay k

eep

rese

rve

sam

ples

for s

horte

r pe

riods

of t

ime,

as n

eces

sary

.

☐

☐

☐

E5.

6(l)(

1) •

Man

ufac

turi

ng sa

mpl

ing

requ

irem

ents

- D

oes t

he o

pera

tion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce to

ens

ure

that

the

rese

rve

sam

ples

of c

anna

bis-

deriv

ed p

rodu

ct is

pro

perly

stor

ed u

sing

the

sam

e co

ntai

ner-

clos

ure

syst

em in

whi

ch th

e pa

ckag

ed a

nd la

bele

d ca

nnab

is-d

eriv

ed

prod

uct i

s dis

tribu

ted

or, f

or b

ulk

prod

ucts

, usi

ng a

con

tain

er-c

losu

re sy

stem

th

at p

rovi

des e

ssen

tially

the

sam

e ch

arac

teris

tics t

o pr

otec

t aga

inst

co

ntam

inat

ion

or d

eter

iora

tion

as th

e on

e in

whi

ch th

e bu

lk p

rodu

ct is

di

strib

uted

?

☐

☐

☐

E5.

6(l)(

2) •

Man

ufac

turi

ng sa

mpl

ing

requ

irem

ents

- D

oes t

he o

pera

tion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce to

ens

ure

that

rese

rve

sam

ples

of c

anna

bis-

deriv

ed p

rodu

ct(s

) are

stor

ed u

nder

con

ditio

ns c

onsi

sten

t w

ith th

e st

orag

e co

nditi

ons r

ecom

men

ded

on th

e pr

oduc

t lab

el o

r, if

no st

orag

e co

nditi

ons a

re re

com

men

ded

on th

e la

bel,

unde

r ord

inar

y st

orag

e co

nditi

ons?

☐

☐

☐

E5.

6(l)(

3) •

Man

ufac

turi

ng sa

mpl

ing

requ

irem

ents

- D

oes t

he o

pera

tion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce to

ens

ure

that

rese

rve

sam

ples

of c

anna

bis-

deriv

ed p

rodu

ct a

re re

tain

ed fo

r one

yea

r pas

t the

ex

pira

tion

date

of t

he b

atch

or l

ot?

Whe

re st

ate

law

lim

its th

e am

ount

of

cann

abis

and

can

nabi

s-de

rived

pro

duct

s per

mitt

ed to

be

kept

on

hand

, op

erat

ions

may

kee

p re

serv

e sa

mpl

es fo

r sho

rter p

erio

ds o

f tim

e, a

s nec

essa

ry.

☐

☐

☐

SAMPLE

E5.

7(a)

(1-2

) • C

anna

bis-

deri

ved

prod

uct s

peci

ficat

ions

- D

oes t

he o

pera

tion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce e

stab

lishi

ng sp

ecifi

catio

ns

for e

ach

cann

abis

-der

ived

pro

duct

? In

clud

ing;

The

esta

blis

hing

spec

ifica

tion

for t

he id

entit

y, p

urity

, stre

ngth

, and

co

mpo

sitio

n of

eac

h ca

nnab

is-d

eriv

ed p

rodu

ct m

anuf

actu

red

by th

e op

erat

ion;

and

If re

ceiv

ing

cann

abis

-der

ived

pro

duct

s for

furth

er p

roce

ssin

g,

spec

ifica

tions

to p

rovi

de su

ffici

ent a

ssur

ance

that

the

prod

uct

rece

ived

is a

dequ

atel

y id

entif

ied

and

is c

onsi

sten

t with

the

purc

hase

or

der.

☐

☐

☐

E5.

7(b)

(1) •

Can

nabi

s-de

rive

d pr

oduc

t spe

cific

atio

ns -

Doe

s the

ope

ratio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

con

firm

ing

that

eac

h ba

tch

or lo

t of c

anna

bis-

deriv

ed p

rodu

ct o

r sub

set o

f can

nabi

s-de

rived

pro

duct

m

anuf

actu

red

by th

e op

erat

ion

has b

een

iden

tifie

d th

roug

h so

und

stat

istic

al

sam

plin

g pl

an?

Doe

s the

ope

ratio

n ve

rify

that

the

batc

h or

lot m

eets

pro

duct

sp

ecifi

catio

ns fo

r ide

ntity

, pur

ity, s

treng

th, a

nd c

ompo

sitio

n, to

the

exte

nt th

at

scie

ntifi

cally

val

id te

st m

etho

ds e

xist

for t

hese

spec

ifica

tions

?

☐

☐

☐

E5.

7(b)

(2) •

Can

nabi

s-de

rive

d pr

oduc

t spe

cific

atio

ns -

Doe

s the

ope

ratio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

con

firm

ing

that

for e

ach

batc

h or

lot o

f can

nabi

s-de

rived

pro

duct

, in

lieu

of te

stin

g ev

ery

esta

blis

hed

stre

ngth

and

com

posi

tion

spec

ifica

tion

for w

hich

scie

ntifi

cally

val

id te

st

met

hods

exi

st, o

ne o

r mor

e st

reng

th a

nd/o

r com

posi

tion

spec

ifica

tions

has

be

en se

lect

ed fo

r tes

ting,

whe

re it

can

be

esta

blis

hed

that

test

ing

for t

his

redu

ced

pane

l of s

peci

ficat

ions

is su

ffici

ent t

o en

sure

that

the

prod

uctio

n an

d pr

oces

s con

trol s

yste

m is

pro

duci

ng p

rodu

ct th

at m

eets

all

spec

ifica

tions

?

☐

☐

☐

E5.

7(b)

(3) •

Can

nabi

s-de

rive

d pr

oduc

t spe

cific

atio

ns -

Doe

s the

ope

ratio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

con

firm

ing

that

for e

ach

batc

h or

lot o

f can

nabi

s-de

rived

pro

duct

, whe

re n

o sc

ient

ifica

lly v

alid

test

m

etho

d ex

ists

for a

pro

duct

spec

ifica

tion,

com

plia

nce

with

the

spec

ifica

tion

has b

een

esta

blis

hed

thro

ugh

com

pone

nt a

nd/o

r in-

proc

ess t

estin

g,

exam

inat

ions

, or m

onito

ring

and/

or re

view

of m

anuf

actu

ring

batc

h re

cord

s?

☐

☐

☐

E5.

7(b)

(4) •

Can

nabi

s-de

rive

d pr

oduc

t spe

cific

atio

ns -

Doe

s the

ope

ratio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

con

firm

ing

that

eac

h ba

tch

or lo

t of c

anna

bis-

deriv

ed p

rodu

ct h

as b

een

appr

oved

by

qual

ity-c

ontro

l pe

rson

nel a

nd ju

stifi

ed fo

r red

uced

pro

duct

test

ing

unde

r sec

tion

5.7(

b)(2

) or

sect

ion

5.7(

b)(3

) of t

his p

art?

☐

☐

☐

SAMPLE

E5.

7(c)

• C

anna

bis-

deri

ved

prod

uct s

peci

ficat

ions

- D

oes t

he o

pera

tion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce c

onfir

min

g th

at e

ach

batc

h or

lot

of c

anna

bis-

deriv

ed p

rodu

ct th

at fa

ils to

mee

t its

spec

ifica

tions

is re

ject

ed,

unle

ss q

ualit

y-co

ntro

l per

sonn

el a

ppro

ve a

trea

tmen

t, pr

oces

s adj

ustm

ent,

repr

oces

sing

, or o

ther

dev

iatio

n th

at e

nsur

es th

e ca

nnab

is-d

eriv

ed p

rodu

ct

batc

hes m

anuf

actu

red

with

the

affe

cted

mat

eria

l will

mee

t all

spec

ifica

tions

for

iden

tity,

pur

ity, s

treng

th, a

nd c

ompo

sitio

n, a

nd w

ill n

ot b

e ot

herw

ise

cont

amin

ated

or a

dulte

rate

d? I

s any

such

trea

tmen

t, pr

oces

s adj

ustm

ent,

repr

oces

sing

, or o

ther

dev

iatio

n do

cum

ente

d in

the

man

ufac

turin

g ba

tch

reco

rd, j

ustif

ied,

and

app

rove

d by

qua

lity-

cont

rol p

erso

nnel

, as r

equi

red?

☐

☐

☐

E5.

7(d)

• C

anna

bis-

deri

ved

prod

uct s

peci

ficat

ions

- D

oes t

he o

pera

tion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce c

onfir

min

g th

at e

ach

batc

h or

lot

of c

anna

bis-

deriv

ed p

rodu

ct e

xper

ienc

ing

any

unex

plai

ned

occu

rren

ce o

r di

scre

panc

y, a

nd a

ny fa

ilure

of t

he c

anna

bis-

deriv

ed p

rodu

ct to

mee

t its

sp

ecifi

catio

ns o

r req

uire

men

ts, h

as b

een

docu

men

ted

and

inve

stig

ated

? Th

e in

vest

igat

ion

mus

t ext

end

to a

ny re

late

d ba

tche

s tha

t may

hav

e be

en a

ssoc

iate

d w

ith th

e sa

me

spec

ific

failu

re, d

iscre

panc

y, o

r pro

blem

; thi

s may

incl

ude,

but

is

not

lim

ited

to, b

atch

es o

f the

sam

e ca

nnab

is-d

eriv

ed p

rodu

ct, o

ther

bat

ches

pr

oces

sed

on th

e sa

me

equi

pmen

t or d

urin

g th

e sa

me

time

perio

d, a

nd

othe

r bat

ches

pro

duce

d us

ing

the

sam

e lo

ts o

f com

pone

nts.

☐

☐

☐

E5.

7(e)

• C

anna

bis-

deri

ved

prod

uct s

peci

ficat

ions

- D

oes t

he o

pera

tion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce d

escr

ibin

g, in

suffi

cien

t det

ail,

the

stor

age,

han

dlin

g, sa

mpl

ing,

test

ing,

and

app

rova

l or r

ejec

tion

of a

ll ca

nnab

is a

nd c

anna

bis-

deriv

ed p

rodu

cts?

☐

☐

☐

SAMPLE

E5.

8(a)

(1-8

) • In

-pro

cess

mat

eria

l spe

cific

atio

ns, s

ampl

ing,

and

test

ing

- D

oes t

he o

pera

tion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce

esta

blis

hing

in-p

roce

ss sp

ecifi

catio

n fo

r any

poi

nt, s

tep,

or s

tage

in th

e m

anuf

actu

ring

prot

ocol

whe

re c

ontro

l is n

eces

sary

to h

elp

ensu

re th

at

spec

ifica

tions

are

met

for t

he id

entit

y, p

urity

, stre

ngth

, and

com

posi

tion

of th

e ca

nnab

is-d

eriv

ed p

rodu

ct?

Such

spec

ifica

tions

may

incl

ude,

but

are

not

lim

ited

to, t

he fo

llow

ing,

as a

ppro

pria

te:

W

eigh

t or f

ill o

f tab

lets

, cap

sule

s, or

oth

er u

nits

;

Wei

ght o

r fill

var

iatio

n of

tabl

ets,

caps

ules

, or o

ther

uni

ts;

H

ardn

ess o

r fria

bilit

y of

tabl

ets;

Dis

inte

grat

ion

time

of u

nit d

osag

es;

C

larit

y, v

isco

sity

, spe

cific

gra

vity

, tot

al d

isso

lved

solid

s, or

pH

of

solu

tions

;

Loss

of d

ryin

g, m

oist

ure

cont

ent,

or s

olve

nt re

sidue

;

Mic

robi

olog

ical

cha

ract

eris

tics;

and

Org

anol

eptic

cha

ract

eris

tics.

☐

☐

☐

E5.

8(b)

• In

-pro

cess

mat

eria

l spe

cific

atio

ns, s

ampl

ing,

and

test

ing

- Doe

s th

e op

erat

ion

have

evi

denc

e th

at th

e in

-pro

cess

spec

ifica

tions

for s

uch

char

acte

ristic

s mee

t the

requ

ired

cons

iste

ncy

with

the

cann

abis

-der

ived

pr

oduc

t spe

cific

atio

ns?

☐

☐

☐

E5.

8(c)

• In

-pro

cess

mat

eria

l spe

cific

atio

ns, s

ampl

ing,

and

test

ing

- Doe

s th

e op

erat

ion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce e

nsur

ing

that

al

l in-

proc

ess m

ater

ials

hav

e be

en sa

mpl

ed a

nd te

sted

or e

xam

ined

for

conf

orm

ance

with

in-p

roce

ss sp

ecifi

catio

ns a

s app

ropr

iate

dur

ing

the

prod

uctio

n pr

oces

s (e.

g., a

t com

men

cem

ent o

r com

plet

ion

of si

gnifi

cant

pr

oces

s sta

ges o

r afte

r sto

rage

for l

ong

perio

ds),

and

whe

re a

ppro

pria

te h

ave

been

app

rove

d or

reje

cted

by

qual

ity-c

ontro

l per

sonn

el?

☐

☐

☐

E5.

8(d)

• In

-pro

cess

mat

eria

l spe

cific

atio

ns, s

ampl

ing,

and

test

ing

- Doe

s th

e op

erat

ion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce e

nsur

ing

that

al

l in-

proc

ess m

ater

ial t

hat f

ails

to m

eet i

ts sp

ecifi

catio

ns a

re re

ject

ed, u

nles

s qu

ality

-con

trol p

erso

nnel

app

rove

a tr

eatm

ent,

proc

ess a

djus

tmen

t, re

proc

essi

ng, o

r oth

er d

evia

tion

that

will

ens

ure

the

cann

abis

-der

ived

pro

duct

ba

tche

s man

ufac

ture

d w

ith th

e af

fect

ed m

ater

ial w

ill m

eet a

ll sp

ecifi

catio

ns fo

r id

entit

y, p

urity

, stre

ngth

, and

com

posi

tion

and

will

not

be

othe

rwis

e co

ntam

inat

ed o

r adu

ltera

ted?

Is a

ny su

ch tr

eatm

ent,

proc

ess a

djus

tmen

t, re

proc

essi

ng, o

r oth

er d

evia

tion

docu

men

ted

in th

e m

anuf

actu

ring

batc

h re

cord

, jus

tifie

d, a

nd a

ppro

ved

by q

ualit

y-co

ntro

l per

sonn

el, a

s req

uire

d?

☐

☐

☐

SAMPLE

E5.

9(a)

• C

alcu

latio

n of

yie

ld -

Doe

s the

ope

ratio

n ha

ve S

OPs

, pro

toco

ls, a

nd

reco

rd k

eepi

ng in

pla

ce e

nsur

ing

that

all

actu

al y

ield

s are

det

erm

ined

at t

he

conc

lusio

n of

eac

h ap

prop

riate

pha

se o

f man

ufac

turin

g of

the

cann

abis

-der

ived

pr

oduc

t? A

re su

ch c

alcu

latio

ns e

ither

per

form

ed b

y on

e pe

rson

and

in

depe

nden

tly v

erifi

ed b

y a

seco

nd p

erso

n, o

r, if

the

yiel

d is

cal

cula

ted

by

auto

mat

ed e

quip

men

t, in

depe

nden

tly v

erifi

ed b

y on

e pe

rson

, as r

equi

red?

☐

☐

☐

E5.

9(b)

• C

alcu

latio

n of

yie

ld -

Doe

s the

ope

ratio

n ha

ve S

OPs

, pro

toco

ls, a

nd

reco

rd k

eepi

ng in

pla

ce e

nsur

ing

that

if th

e pe

rcen

tage

of t

heor

etic

al y

ield

, at

any

proc

ess s

tep

or a

t the

end

of p

rodu

ctio

n, fa

lls o

utsid

e th

e m

axim

um o

r m

inim

um p

erce

ntag

e of

theo

retic

al y

ield

allo

wed

in th

e m

anuf

actu

ring

prot

ocol

, tha

t qua

lity-

cont

rol p

erso

nnel

are

requ

ired

to c

ondu

ct a

n in

vest

igat

ion

of th

e ba

tch

and

dete

rmin

e, to

the

exte

nt p

ossi

ble,

the

sour

ce o

f th

e di

scre

panc

y? A

re d

evia

tions

doc

umen

ted,

exp

lain

ed, a

nd a

ppro

ved

by

qual

ity-c

ontro

l per

sonn

el, a

s req

uire

d?.

☐

☐

☐

F6.1

(a) •

Gen

eral

con

side

ratio

n fo

r pa

ckag

ing

com

pone

nts,

incl

udin

g la

bels

- D

oes t

he o

pera

tion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce

for c

anna

bis t

o be

pac

kage

d w

ithou

t und

ergo

ing

man

ufac

turin

g to

a c

anna

bis-

deriv

ed p

rodu

ct, d

ocum

entin

g it

as re

ceiv

ed, i

dent

ified

, sto

red,

han

dled

, sa

mpl

ed, r

evie

wed

, and

app

rove

d or

reje

cted

as p

er se

ctio

ns 5

.2 a

nd 5

.6

abov

e?

☐

☐

☐

F6.1

(b) •

Gen

eral

con

side

ratio

n fo

r pa

ckag

ing

com

pone

nts,

incl

udin

g la

bels

- D

oes t

he o

pera

tion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce

esta

blis

hing

spec

ifica

tions

for p

acka

ging

com

pone

nts a

s nec

essa

ry to

ens

ure

the

iden

tity,

pur

ity, s

treng

th, a

nd c

ompo

sitio

n of

the

pack

aged

pro

duct

s?

Pack

agin

g co

mpo

nent

s tha

t may

com

e in

to c

onta

ct w

ith p

rodu

cts m

ust b

e sa

fe

and

suita

ble

for t

heir

inte

nded

use

and

mus

t not

be

reac

tive

or a

bsor

ptiv

e or

ot

herw

ise

affe

ct th

e sa

fety

, pur

ity, o

r qua

lity

of th

e pr

oduc

t.

☐

☐

☐

F6.1

(c) •

Gen

eral

con

side

ratio

n fo

r pa

ckag

ing

com

pone

nts,

incl

udin

g la

bels

- D

oes t

he p

acka

ging

and

labe

ling

oper

atio

n ha

ve w

ritte

n SO

Ps,

prot

ocol

s, an

d re

cord

kee

ping

in p

lace

est

ablis

hing

pro

cedu

res d

escr

ibin

g, in

su

ffici

ent d

etai

l, th

e re

ceip

t, id

entif

icat

ion,

stor

age,

han

dlin

g, a

nd a

ppro

val o

r re

ject

ion

of p

acka

ging

and

labe

ling

com

pone

nts?

☐

☐

☐

SAMPLE

F6.1

(d)(

1) •

Gen

eral

con

side

ratio

n fo

r pa

ckag

ing

com

pone

nts,

incl

udin

g la

bels

- D

oes t

he o

pera

tion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in

pla

ce fo

r the

rece

ivin

g an

d st

orag

e of

labe

ls a

nd o

ther

pac

kagi

ng

com

pone

nts t

o en

sure

that

, upo

n re

ceip

t and

bef

ore

acce

ptan

ce, e

ach

cont

aine

r or

gro

upin

g of

con

tain

ers o

f pac

kagi

ng c

ompo

nent

s is v

isua

lly e

xam

ined

for

appr

opria

te la

belin

g as

to c

onte

nts,

cont

aine

r dam

age

or b

roke

n se

als,

and

cont

amin

atio

n, to

det

erm

ine

whe

ther

the

cont

aine

r con

ditio

n m

ay h

ave

resu

lted

in c

onta

min

atio

n or

det

erio

ratio

n of

the

pack

agin

g co

mpo

nent

s?

☐

☐

☐

F6.1

(d)(

2) •

Gen

eral

con

side

ratio

n fo

r pa

ckag

ing

com

pone

nts,

incl

udin

g la

bels

- D

oes t

he o

pera

tion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in

pla

ce v

erify

ing

that

the

supp

lier’

s doc

umen

tatio

n fo

r eac

h sh

ipm

ent h

as

been

exa

min

ed to

ens

ure

the

pack

agin

g co

mpo

nent

s are

con

sist

ent w

ith w

hat

was

ord

ered

?

☐

☐

☐

F6.1

(d)(

3) •

Gen

eral

con

side

ratio

n fo

r pa

ckag

ing

com

pone

nts,

incl

udin

g la

bels

- D

oes t

he o

pera

tion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in

pla

ce e

nsur

ing

that

eac

h co

ntai

ner o

r gro

upin

g of

con

tain

ers f

or p

acka

ging

co

mpo

nent

s has

bee

n id

entif

ied

with

a d

istin

ctiv

e co

de (i

.e. l

ot o

r con

trol

num

ber)

for e

ach

lot i

n ea

ch sh

ipm

ent r

ecei

ved,

whi

ch a

llow

s the

lot t

o be

tra

ced

back

war

d to

the

supp

lier,

incl

udin

g th

e da

te re

ceiv

ed, a

nd th

e na

me

of

the

com

pone

nt, a

nd fo

rwar

ded

to th

e pr

oduc

t bat

ches

pac

kage

d or

labe

led

usin

g th

e lo

t? T

his c

ode

mus

t be

used

in re

cord

ing

the

disp

ositi

on o

f eac

h lo

t.

☐

☐

☐

F6.1

(d)(

4) •

Gen

eral

con

side

ratio

n fo

r pa

ckag

ing

com

pone

nts,

incl

udin

g la

bels

- D

oes t

he o

pera

tion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in

pla

ce e

nsur

ing

that

labe

ls a

nd o

ther

pac

kagi

ng c

ompo

nent

s are

stor

ed u

nder

qu

aran

tine

until

they

hav

e be

en e

xam

ined

and

app

rove

d or

reje

cted

by

qual

ity-

cont

rol p

erso

nnel

?

☐

☐

☐

F6.1

(e)(1

) • G

ener

al c

onsi

dera

tion

for

pack

agin

g co

mpo

nent

s, in

clud

ing

labe

ls -

Doe

s the

ope

ratio

n ha

ve w

ritte

n SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng

in p

lace

ens

urin

g th

at p

acka

ging

com

pone

nts a

re w

ithhe

ld fr

om u

se u

ntil

the

lot h

as b

een

revi

ewed

and

rele

ased

for u

se b

y th

e qu

ality

-con

trol p

erso

nnel

?

☐

☐

☐

F6.1

(e)(2

) • G

ener

al c

onsi

dera

tion

for

pack

agin

g co

mpo

nent

s, in

clud

ing

labe

ls -

Doe

s the

ope

ratio

n ha

ve w

ritte

n SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng

in p

lace

ens

urin

g th

at p

acka

ging

com

pone

nts a

re in

com

plia

nce

with

es

tabl

ishe

d sp

ecifi

catio

ns a

nd h

ave

been

thor

ough

ly e

xam

ined

upo

n re

ceip

t, an

d/or

has

und

ergo

ne a

revi

ew o

f the

supp

lier’

s doc

umen

tatio

n?

☐

☐

☐

SAMPLE

F6.1

(e)(3

) • G

ener

al c

onsi

dera

tion

for

pack

agin

g co

mpo

nent

s, in

clud

ing

labe

ls -

Doe

s the

ope

ratio

n ha

ve w

ritte

n SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng

in p

lace

ens

urin

g th

at a

ll sh

ipm

ents

of a

pac

kagi

ng c

ompo

nent

hav

e be

en

dete

rmin

ed to

mee

t its

spec

ifica

tion

and

rele

ased

for u

se b

y qu

ality

-con

trol

pers

onne

l?

☐

☐

☐

F6.1

(e)(4

) • G

ener

al c

onsi

dera

tion

for

pack

agin

g co

mpo

nent

s, in

clud

ing

labe

ls -

Doe

s the

ope

ratio

n ha

ve w

ritte

n SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng

in p

lace

ens

urin

g th

at a

ll pa

ckag

ing

com

pone

nt th

at d

oes n

ot m

eet i

ts

spec

ifica

tions

, inc

ludi

ng a

ny in

corr

ect l

abel

s, ar

e re

ject

ed b

y qu

ality

-con

trol

pers

onne

l, un

less

qua

lity-

cont

rol p

erso

nnel

app

rove

a tr

eatm

ent o

r oth

er

devi

atio

n th

at w

ill re

nder

the

pack

agin

g co

mpo

nent

suita

ble

for u

se, a

nd w

ill

ensu

re th

e pr

oduc

t bat

ches

pac

kage

d an

d la

bele

d w

ith th

e af

fect

ed c

ompo

nent

w

ill m

eet a

ll sp

ecifi

catio

ns fo

r ide

ntity

, pur

ity, s

treng

th, c

ompo

sitio

n,

pack

agin

g, a

nd la

belin

g an

d w

ill n

ot b

e ot

herw

ise

cont

amin

ated

or a

dulte

rate

d?

Is a

ny su

ch tr

eatm

ent o

r oth

er d

evia

tion

docu

men

ted,

just

ified

, and

app

rove

d by

qua

lity-

cont

rol p

erso

nnel

, as r

equi

red?

☐

☐

☐

F6.1

(f) •

Gen

eral

con

side

ratio

n fo

r pa

ckag

ing

com

pone

nts,

incl

udin

g la

bels

- D

oes t

he o

pera

tion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in

pla

ce p

rohi

bitin

g th

e us

e of

gan

g-pr

inte

d la

belin

g fo

r diff

eren

t pro

duct

s, or

di

ffere

nt st

reng

ths o

r net

con

tent

s of t

he sa

me

prod

uct,

unle

ss th

e la

belin

g fro

m

gang

-prin

ted

shee

ts is

ade

quat

ely

diffe

rent

iate

d by

size

, sha

pe, o

r col

or?

☐

☐

☐

F6.2

(a)(

1) •

Pack

agin

g an

d/or

labe

ling

prot

ocol

- D

oes t

he p

acka

ging

and

la

belin

g op

erat

ion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

fo

r eac

h un

ique

pro

duct

to b

e pa

ckag

ed a

nd/o

r lab

eled

that

ass

ures

the

corr

ect

pack

agin

g an

d la

belin

g co

mpo

nent

s are

use

d fo

r eac

h pr

oduc

t pac

kage

d or

la

bele

d by

the

oper

atio

n in

clud

ing

the

iden

tity

of th

e pr

oduc

t to

be p

acka

ged

and/

or la

bele

d? W

here

app

ropr

iate

, the

pac

kagi

ng a

nd/o

r lab

elin

g pr

otoc

ol

may

be

com

bine

d w

ith th

e m

anuf

actu

ring

prot

ocol

for t

he p

rodu

ct.

☐

☐

☐

F6.2

(a)(

2) •

Pack

agin

g an

d/or

labe

ling

prot

ocol

- D

oes t

he p

acka

ging

and

la

belin

g op

erat

ion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

fo

r eac

h un

ique

pro

duct

to b

e pa

ckag

ed a

nd/o

r lab

eled

that

ass

ures

the

corr

ect

pack

agin

g an

d la

belin

g co

mpo

nent

s are

use

d fo

r eac

h pr

oduc

t pac

kage

d or

la

bele

d by

the

oper

atio

n, in

clud

ing

the

iden

tity

of e

ach

pack

agin

g co

mpo

nent

to

be

used

? W

here

app

ropr

iate

, the

pac

kagi

ng a

nd/o

r lab

elin

g pr

otoc

ol m

ay b

e co

mbi

ned

with

the

man

ufac

turin

g pr

otoc

ol fo

r the

pro

duct

.

☐

☐

☐

SAMPLE

F6.2

(a)(

3) •

Pack

agin

g an

d/or

labe

ling

prot

ocol

- D

oes t

he p

acka

ging

and

la

belin

g op

erat

ion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

fo

r eac

h un

ique

pro

duct

to b

e pa

ckag

ed a

nd/o

r lab

eled

that

ass

ures

the

corr

ect

pack

agin

g an

d la

belin

g co

mpo

nent

s are

use

d fo

r eac

h pr

oduc

t pac

kage

d or

la

bele

d by

the

oper

atio

n in

clud

ing

prov

idin

g a

spec

imen

of t

he la

bel a

nd o

ther

la

belin

g to

be

used

, or a

cro

ss-r

efer

ence

to th

e la

belin

g (s

uch

as b

y la

bel

num

ber a

nd v

ersi

on n

umbe

r)?

Whe

re a

ppro

pria

te, t

he p

acka

ging

and

/or

labe

ling

prot

ocol

may

be

com

bine

d w

ith th

e m

anuf

actu

ring

prot

ocol

for t

he

prod

uct.

☐

☐

☐

F6.2

(a)(

4) •

Pack

agin

g an

d/or

labe

ling

prot

ocol

- D

oes t

he p

acka

ging

and

la

belin

g op

erat

ion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

fo

r eac

h un

ique

pro

duct

to b

e pa

ckag

ed a

nd/o

r lab

eled

that

ass

ures

the

corr

ect

pack

agin

g an

d la

belin

g co

mpo

nent

s are

use

d fo

r eac

h pr

oduc

t pac

kage

d or

la

bele

d by

the

oper

atio

n pr

ovid

ing

a st

atem

ent o

f the

acc

epta

ble

max

imum

and

m

inim

um p

erce

ntag

es o

f the

oret

ical

yie

ld?

☐

☐

☐

F6.2

(a)(

5)(i-

vi) •

Pac

kagi

ng a

nd/o

r la

belin

g pr

otoc

ol -

Doe

s the

pac

kagi

ng

and

labe

ling

oper

atio

n ha

ve w

ritte

n SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pl

ace

for e

ach

uniq

ue p

rodu

ct to

be

pack

aged

and

/or l

abel

ed th

at a

ssur

es th

e co

rrec

t pac

kagi

ng a

nd la

belin

g co

mpo

nent

s are

use

d fo

r eac

h pr

oduc

t pa

ckag

ed o

r lab

eled

by

the

oper

atio

n, to

incl

ude

writ

ten

inst

ruct

ions

or c

ross

re

fere

nces

to st

anda

rd p

roce

dure

s for

the

follo

win

g?

In

spec

tion

of p

acka

ging

and

labe

ling

equi

pmen

t bef

ore

and

afte

r use

to

ass

ure

that

all

prod

ucts

and

pac

kagi

ng a

nd la

belin

g m

ater

ials

from

pr

evio

us o

pera

tions

hav

e be

en re

mov

ed;

Is

suan

ce o

f lab

els a

nd la

belin

g an

d la

belin

g sp

ecifi

ed in

the

pack

agin

g an

d/or

labe

ling

prot

ocol

;

Car

eful

exa

min

atio

n of

labe

ls a

nd la

belin

g is

sued

to e

ach

batc

h pr

ior

to u

se, t

o en

sure

con

form

ity to

the

labe

ling

spec

ified

in th

e pa

ckag

ing

and/

or la

belin

g pr

otoc

ol;

Ea

ch p

acka

ging

and

/or l

abel

ing

proc

ess s

tep;

Mon

itorin

g of

pac

kagi

ng a

nd/o

r lab

elin

g pr

oces

s ste

ps; a

nd

A

dditi

onal

app

licab

le p

roce

dure

s to

be fo

llow

ed, i

f any

.

☐

☐

☐

F6.2

(b) •

Pac

kagi

ng a

nd/o

r la

belin

g pr

otoc

ol -

Doe

s the

ope

ratio

n ha

ve

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

ens

urin

g th

at th

e pa

ckag

ing

and/

or la

belin

g pr

oces

s mee

ts a

ll pr

oduc

t spe

cific

atio

ns?

☐

☐

☐

SAMPLE

F6.2

(c) •

Pac

kagi

ng a

nd/o

r la

belin

g pr

otoc

ol -

Doe

s the

ope

ratio

n ha

ve

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

for t

he p

acka

ging

and

/or

labe

ling

proc

ess d

escr

ibed

in th

e pr

otoc

ols t

hat e

nsur

e th

e pr

oduc

t sp

ecifi

catio

ns a

re c

onsi

sten

tly m

et?

☐

☐

☐

F6.3

(a) •

Pac

kagi

ng a

nd/o

r la

belin

g ba

tch

reco

rd -

Doe

s the

ope

ratio

n ha

ve

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

for t

he p

repa

ratio

n of

a

pack

agin

g an

d/or

labe

ling

batc

h re

cord

for e

ach

batc

h or

lot o

f pro

duct

pa

ckag

ed a

nd/o

r lab

eled

by

the

oper

atio

n? W

here

app

ropr

iate

, the

pac

kagi

ng

and

labe

ling

batc

h re

cord

may

be

com

bine

d w

ith th

e m

anuf

actu

ring

batc

h re

cord

for t

he b

atch

or l

ot.

☐

☐

☐

F6.3

(b)(

1-2)

• Pa

ckag

ing

and/

or la

belin

g ba

tch

reco

rd -

Doe

s the

ope

ratio

n ha

ve w

ritte

n SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce fo

r the

pac

kagi

ng

and/

or la

belin

g of

bat

ch re

cord

s, in

clud

ing

cros

s-re

fere

nce

or re

prod

uctio

n of

ap

prop

riate

pac

kagi

ng a

nd/o

r lab

elin

g pr

otoc

ol, a

nd a

com

plet

e re

cord

of t

he

pack

agin

g an

d/or

labe

ling

and

sam

plin

g of

the

batc

h?

☐

☐

☐

F6.3

(c)(1

-3) •

Pac

kagi

ng a

nd/o

r la

belin

g ba

tch

reco

rd -

Doe

s the

ope

ratio

n ha

ve w

ritte

n SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce fo

r the

pac

kagi

ng

and/

or la

belin

g w

ith b

atch

reco

rds i

nclu

ding

, as a

pplic

able

to th

e pr

oces

s, th

e id

entit

y of

the

prod

uct;

batc

h, lo

t, or

con

trol n

umbe

r of t

he p

rodu

ct; p

acka

ging

an

d/or

labe

ling

batc

h si

ze?

☐

☐

☐

F6.3

(c)(4

)(i-i

ii) •

Pack

agin

g an

d/or

labe

ling

batc

h re

cord

- D

oes t

he

oper

atio

n ha

ve w

ritte

n SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce fo

r pa

ckag

ing

and/

or la

belin

g of

bat

ch re

cord

s tha

t inc

lude

, as a

pplic

able

to th

e pr

oces

s, fo

r eac

h pa

ckag

ing

com

pone

nt u

sed

in th

e pr

oduc

tion

of th

e ba

tch,

the

follo

win

g in

form

atio

n:

Id

entit

y of

eac

h pa

ckag

ing

com

pone

nt;

B

atch

, lot

, or c

ontro

l num

ber o

f eac

h pa

ckag

ing

com

pone

nt u

sed

in

the

batc

h;

Q

uant

ity o

f eac

h lo

t of p

acka

ging

com

pone

nts u

sed,

incl

udin

g th

e un

it of

mea

sure

.

☐

☐

☐

F6.3

(c)(5

) • P

acka

ging

and

/or

labe

ling

batc

h re

cord

- D

oes t

he o

pera

tion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

for p

acka

ging

an

d/or

labe

ling

of b

atch

reco

rds t

hat i

nclu

de th

e da

te(s

) on

whi

ch, a

nd w

here

ap

plic

able

, the

tim

es a

t whi

ch, e

ach

step

of t

he p

acka

ging

and

/or l

abel

ing

prot

ocol

was

per

form

ed?

☐

☐

☐

SAMPLE

F6.3

(c)(6

) • P

acka

ging

and

/or

labe

ling

batc

h re

cord

- D

oes t

he o

pera

tion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

for p

acka

ging

an

d/or

labe

ling

of b

atch

reco

rds i

nclu

ding

the

iden

tity

of p

acka

ging

line

s and

m

ajor

equ

ipm

ent u

sed

in p

acka

ging

and

/or l

abel

ing

the

batc

h?

☐

☐

☐

F6.3

(c)(7

) • P

acka

ging

and

/or

labe

ling

batc

h re

cord

- D

oes t

he o

pera

tion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

for p

acka

ging

an

d/or

labe

ling

of b

atch

reco

rds i

nclu

ding

the

date

and

tim

e of

the

mai

nten

ance

, cle

anin

g, a

nd/o

r san

itizi

ng o

f the

pac

kagi

ng li

nes a

nd m

ajor

eq

uipm

ent u

sed

in p

acka

ging

and

labe

ling

of th

e ba

tch,

or a

cro

ss-r

efer

ence

to

reco

rds,

such

as i

ndiv

idua

l equ

ipm

ent l

ogs,

whe

re th

is in

form

atio

n is

re

cord

ed?

☐

☐

☐

F6.3

(c)(8

) • P

acka

ging

and

/or

labe

ling

batc

h re

cord

- D

oes t

he o

pera

tion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

for p

acka

ging

an

d/or

labe

ling

of b

atch

reco

rds,

incl

udin

g, if

pac

kagi

ng o

r lab

elin

g of

the

batc

h us

es e

quip

men

t or i

nstru

men

ts re

quiri

ng p

erio

dic

calib

ratio

n, in

spec

tion,

or

ver

ifica

tion,

the

date

and

tim

e of

the

last

cal

ibra

tion,

insp

ectio

n, o

r oth

er

verif

icat

ion

of in

stru

men

ts o

r equ

ipm

ent o

r the

dat

e on

whi

ch s

uch

is n

ext d

ue,

or a

cro

ss-r

efer

ence

to re

cord

s, su

ch a

s ind

ivid

ual e

quip

men

t log

s, w

here

this

in

form

atio

n is

reco

rded

?

☐

☐

☐

F6.3

(c)(9

) • P

acka

ging

and

/or

labe

ling

batc

h re

cord

- D

oes t

he o

pera

tion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

for p

acka

ging

an

d/or

labe

ling

of b

atch

reco

rds i

nclu

ding

a st

atem

ent o

f act

ual y

ield

and

a

stat

emen

t reg

ardi

ng w

heth

er th

e ac

tual

yie

ld is

with

in th

e ac

cept

able

rang

e of

th

e th

eore

tical

yie

ld a

s per

sect

ion

6.2(

a)(4

) at t

he e

nd o

f pac

kagi

ng a

nd/o

r la

belin

g?

☐

☐

☐

F6.3

(c)(1

0) •

Pack

agin

g an

d/or

labe

ling

batc

h re

cord

- D

oes t

he o

pera

tion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

for p

acka

ging

an

d/or

labe

ling

of b

atch

reco

rds i

nclu

ding

doc

umen

tatio

n fo

r whe

n th

e ac

tual

yi

eld

falls

out

side

the

allo

wed

lim

its, q

ualit

y-co

ntro

l per

sonn

el m

ust c

ondu

ct

an in

vest

igat

ion

of th

e ba

tch

and

dete

rmin

e, to

the

exte

nt p

ossi

ble,

the

sour

ce

of th

e di

scre

panc

y? T

he d

evia

tion

mus

t be

docu

men

ted,

exp

lain

ed, a

nd

appr

oved

by

qual

ity-c

ontro

l per

sonn

el.

☐

☐

☐

F6.3

(c)(1

1) •

Pack

agin

g an

d/or

labe

ling

batc

h re

cord

- D

oes t

he o

pera

tion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

for p

acka

ging

an

d/or

labe

ling

of b

atch

reco

rds i

nclu

ding

labe

l rec

onci

liatio

n, a

s per

sect

ion

6.3(

f) of

this

par

t?

☐

☐

☐

SAMPLE

F6.3

(c)(1

2) •

Pack

agin

g an

d/or

labe

ling

batc

h re

cord

- D

oes t

he o

pera

tion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

for p

acka

ging

an

d/or

labe

ling

of b

atch

reco

rds i

nclu

ding

reco

rds o

f any

labe

ling

scra

p or

ca

nnab

is w

aste

gen

erat

ed d

urin

g pa

ckag

ing

and

/or l

abel

ing

of th

e ba

tch?

☐

☐

☐

F6.3

(c)(1

3)(i-

vi) •

Pac

kagi

ng a

nd/o

r la

belin

g ba

tch

reco

rd -

Doe

s the

op

erat

ion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

for

pack

agin

g an

d/or

labe

ling

of b

atch

reco

rds,

incl

udin

g re

cord

s ide

ntify

ing

each

pe

rson

per

form

ing

each

pro

cess

step

in p

acka

ging

and

/or l

abel

ing

of th

e ba

tch?

Th

is in

clud

es b

ut is

not

lim

ited

to:

In

spec

ting

labe

ls a

nd o

ther

pac

kagi

ng c

ompo

nent

s to

ensu

re

suita

bilit

y an

d co

rrec

tnes

s prio

r to

use

in th

e ba

tch;

Insp

ectin

g pa

ckag

ing

and

labe

ling

area

s bef

ore

and

afte

r use

;

Rec

onci

ling

labe

l iss

uanc

e an

d us

age

and

verif

ying

the

reco

ncili

atio

n of

labe

l iss

uanc

e an

d us

age;

Exam

inin

g pa

ckag

ed a

nd la

bele

d pr

oduc

ts to

ens

ure

prop

er la

belin

g an

d co

ding

;

Perfo

rmin

g an

y ot

her c

heck

s or v

erifi

catio

ns in

pac

kagi

ng a

nd/o

r la

belin

g of

the

batc

h as

nee

ded;

and

Rel

easi

ng th

e ba

tch

from

one

stag

e of

pac

kagi

ng a

nd/o

r lab

elin

g to

th

e ne

xt.

☐

☐

☐

F6.3

(d) •

Pac

kagi

ng a

nd/o

r la

belin

g ba

tch

reco

rd -

Doe

s the

ope

ratio

n ha

ve

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

for p

acka

ging

and

/or

labe

ling

of b

atch

reco

rds,

incl

udin

g th

e re

cord

ing

of a

ll da

ta, a

t the

tim

e at

w

hich

eac

h ac

tion

was

per

form

ed?

☐

☐

☐

F6.3

(e)(1

-2) •

Pac

kagi

ng a

nd/o

r la

belin

g ba

tch

reco

rd -

Doe

s the

ope

ratio

n ha

ve w

ritte

n SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce fo

r pac

kagi

ng

and/

or la

belin

g of

bat

ch re

cord

s ens

urin

g th

at a

ll pr

intin

g de

vice

s loc

ated

on,

or

ass

ocia

ted

with

, pro

duct

ion

lines

are

mon

itore

d to

ass

ure

that

all

prin

ting

conf

orm

s to

the

requ

irem

ents

of t

he p

acka

ging

and

/or l

abel

ing

prot

ocol

use

d to

im

prin

t lab

elin

g or

cod

ing

dire

ctly

on

the

follo

win

g?

Pr

imar

y pa

ckag

ing

for t

he p

rodu

ct;

Se

cond

ary

pack

agin

g (e

.g.,

a ca

se c

onta

inin

g se

vera

l ind

ivid

ual

pack

ages

of p

rodu

ct).

☐

☐

☐

SAMPLE

F6.3

(f)(1

) • P

acka

ging

and

/or

labe

ling

batc

h re

cord

- D

oes t

he p

acka

ging

an

d la

belin

g op

erat

ion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in

plac

e re

conc

iling

the

quan

titie

s of l

abel

s or l

abel

ing

issu

ed, u

sed,

and

retu

rned

to

stor

age,

that

est

ablis

hes n

arro

w li

mits

for t

he la

belin

g re

conc

iliat

ion

to b

e ba

sed,

whe

re p

ossi

ble,

on

histo

rical

ope

ratin

g da

ta, f

or th

e am

ount

of a

llow

ed

varia

tion

in th

e la

belin

g re

conc

iliat

ion?

☐

☐

☐

F6.3

(f)(2

) • P

acka

ging

and

/or

labe

ling

batc

h re

cord

- D

oes t

he p

acka

ging

an

d la

belin

g op

erat

ion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in

plac

e re

conc

iling

whe

n la

belin

g fa

lls o

utsid

e th

e al

low

ed li

mits

such

that

qu

ality

-con

trol p

erso

nnel

mus

t con

duct

an

inve

stig

atio

n of

the

batc

h an

d de

term

ine,

to th

e ex

tent

pos

sibl

e, th

e so

urce

of t

he d

iscr

epan

cy?

The

dev

iatio

n m

ust b

e do

cum

ente

d, e

xpla

ined

, and

app

rove

d by

qua

lity-

cont

rol p

erso

nnel

.

☐

☐

☐

F6.3

(f)(3

) • P

acka

ging

and

/or

labe

ling

batc

h re

cord

- D

oes t

he p

acka

ging

an

d la

belin

g op

erat

ion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in

plac

e do

cum

entin

g al

l rec

onci

liatio

n w

aive

d fo

r cut

or r

oll l

abel

s if a

100

%

exam

inat

ion

for c

orre

ct la

bels

has

bee

n pe

rform

ed, e

ither

man

ually

or b

y ap

prop

riate

ele

ctro

nic

or e

lect

rom

echa

nica

l equ

ipm

ent d

urin

g or

afte

r co

mpl

etio

n of

fini

shin

g op

erat

ions

?

☐

☐

☐

F6.3

(f)(4

) • P

acka

ging

and

/or

labe

ling

batc

h re

cord

- D

oes t

he p

acka

ging

an

d la

belin

g op

erat

ion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in

plac

e re

quiri

ng a

ll ex

cess

labe

ling

bear

ing

batc

h, lo

t, or

con

trol n

umbe

rs b

e de

stro

yed?

☐

☐

☐

F6.3

(f)(5

) • P

acka

ging

and

/or

labe

ling

batc

h re

cord

- D

oes t

he p

acka

ging

an

d la

belin

g op

erat

ion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in

plac

e ou

tlini

ng th

e ca

re th

at m

ust b

e ta

ken

whe

n re

turn

ing

labe

ling

to st

orag

e,

to p

reve

nt m

ix-u

ps, a

nd e

nsur

ing

prop

er id

entif

icat

ion?

☐

☐

☐

F6.3

(g) •

Pac

kagi

ng a

nd/o

r la

belin

g ba

tch

reco

rd -

Doe

s the

pac

kagi

ng a

nd

labe

ling

oper

atio

n ha

ve w

ritte

n SO

Ps, p

roto

cols,

and

reco

rd k

eepi

ng in

pla

ce

iden

tifyi

ng re

pres

enta

tive

and

rese

rve

sam

ples

of e

ach

batc

h or

lot o

f ret

ail

pack

aged

and

/or l

abel

ed p

rodu

ct, a

s req

uire

d to

be

colle

cted

per

sect

ion

5.6

of

this

par

t?

☐

☐

☐

SAMPLE

F6.3

(h) •

Pac

kagi

ng a

nd/o

r la

belin

g ba

tch

reco

rd -

Doe

s the

pac

kagi

ng a

nd

labe

ling

oper

atio

n ha

ve w

ritte

n SO

Ps, p

roto

cols,

and

reco

rd k

eepi

ng in

pla

ce

notin

g th

e co

mpl

eted

pac

kagi

ng a

nd/o

r lab

elin

g ba

tch

reco

rd fo

r eac

h ba

tch

or

lot?

The

se re

cord

s muc

h be

revi

ewed

and

sign

ed b

y qu

ality

-con

trol p

erso

nnel

to

det

erm

ine

com

plia

nce

with

all

appl

icab

le sp

ecifi

catio

ns a

nd o

ther

re

quire

men

ts o

f the

pac

kagi

ng a

nd/o

r lab

elin

g pr

otoc

ol b

efor

e a

batc

h or

lot i

s ap

prov

ed.

☐

☐

☐

F6.3

(i) •

Pack

agin

g an

d/or

labe

ling

batc

h re

cord

- D

oes t

he p

acka

ging

and

la

belin

g op

erat

ion

have

writ

ten

SOPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

en

surin

g th

at p

acka

ged

or la

bele

d pr

oduc

ts th

at fa

il to

mee

t pac

kagi

ng o

r la

belin

g sp

ecifi

catio

ns o

r oth

er p

acka

ging

requ

irem

ents

are

reje

cted

, unl

ess

qual

ity-c

ontro

l per

sonn

el a

ppro

ve re

pack

agin

g, re

labe

ling,

or o

ther

dev

iatio

n th

at e

nsur

es th

e pr

oduc

t bat

ch o

r lot

will

mee

t all

pack

agin

g an

d la

belin

g sp

ecifi

catio

ns a

nd o

ther

pac

kagi

ng re

quire

men

ts, a

nd w

ill n

ot b

e ot

herw

ise

cont

amin

ated

or a

dulte

rate

d? A

ny su

ch re

pack

agin

g, re

labe

ling,

or o

ther

de

viat

ion

mus

t be

docu

men

ted,

just

ified

, and

app

rove

d by

qua

lity-

cont

rol

pers

onne

l.

☐

☐

☐

F6.4

(a)(

1-4)

• L

abel

con

tent

for

cann

abis

and

can

nabi

s-de

rive

d pr

oduc

ts -

Doe

s the

pac

kagi

ng a

nd la

belin

g op

erat

ion

have

writ

ten

SOPs

, pro

toco

ls, a

nd

reco

rd k

eepi

ng in

pla

ce e

nsur

ing

that

pac

kage

d or

labe

led

prod

ucts

bea

r on

the

labe

l of i

ts p

rimar

y pa

ckag

ing

the

nam

e an

d pl

ace

of b

usin

ess o

f the

m

anuf

actu

rer o

r dis

tribu

tor;

iden

tity

of th

e pr

oduc

t; ne

t qua

ntity

of c

onte

nts i

n te

rms o

f wei

ght,

num

eric

al c

ount

, or o

ther

app

ropr

iate

mea

sure

; and

a b

atch

, lo

t, or

con

trol n

umbe

r?

☐

☐

☐

F6.4

(a)(

5) •

Lab

el c

onte

nt fo

r ca

nnab

is a

nd c

anna

bis-

deri

ved

prod

ucts

- D

oes t

he p

acka

ging

and

labe

ling

oper

atio

n ha

ve w

ritte

n SO

Ps, p

roto

cols

, and

re

cord

kee

ping

in p

lace

ens

urin

g th

at p

acka

ged

or la

bele

d pr

oduc

ts b

ear o

n th

e la

bel o

f its

prim

ary

pack

agin

g ei

ther

a p

rodu

ctio

n da

te o

r an

expi

ratio

n da

te?

Pr

oduc

ts c

apab

le o

f sup

porti

ng th

e ra

pid

and

prog

ress

ive

grow

th o

f inf

ectio

us,

toxi

geni

c, o

r spo

ilage

mic

roor

gani

sms m

ust b

ear a

“us

e by

” da

te a

nd/o

r a

“fre

eze

by”

date

. Any

shel

f life

or e

xpira

tion

perio

d in

dica

ted

on th

e la

bel o

f an

edi

ble

prod

uct m

ust b

e su

ppor

ted

by a

ppro

pria

te d

ata.

☐

☐

☐

SAMPLE

F6.4

(a)(

6-9)

• L

abel

con

tent

for

cann

abis

and

can

nabi

s-de

rive

d pr

oduc

ts -

Doe

s the

pac

kagi

ng a

nd la

belin

g op

erat

ion

have

writ

ten

SOPs

, pro

toco

ls, a

nd

reco

rd k

eepi

ng in

pla

ce e

nsur

ing

that

pac

kage

d or

labe

led

prod

ucts

bea

r on

the

labe

l of i

ts p

rimar

y pa

ckag

ing

inst

ruct

ion

for u

se, i

nclu

ding

any

type

s of

com

plia

nt in

divi

dual

s for

who

m th

e pr

oduc

t is r

ecom

men

ded,

as a

ppro

pria

te;

inst

ruct

ions

for a

ppro

pria

te st

orag

e; a

nd a

ny o

ther

stat

emen

ts o

r inf

orm

atio

n re

quire

d by

stat

e re

gula

tors

?

☐

☐

☐

F6.4

(b)(

1-11

) • L

abel

con

tent

for

cann

abis

and

can

nabi

s-de

rive

d pr

oduc

ts

- Doe

s the

pac

kagi

ng a

nd la

belin

g op

erat

ion

have

writ

ten

SOPs

, pro

toco

ls, a

nd

reco

rd k

eepi

ng in

pla

ce e

nsur

ing

that

pac

kage

d or

labe

led

prod

ucts

bea

r on

the

labe

l of p

rimar

y pa

ckag

ing

for a

ll ed

ible

pro

duct

s a “

Prod

uct F

acts

” bo

x lis

ting

quan

titat

ive

cont

ent a

nd n

utrie

nt in

form

atio

n re

leva

nt to

the

prod

uct,

incl

udin

g,

as a

pplic

able

, the

follo

win

g co

nten

t?

C

anna

bis i

ngre

dien

t;

Can

nabi

noid

and

/or t

erpe

noid

con

tent

;

Tota

l cal

orie

s and

fat c

alor

ies (

whe

n gr

eate

r tha

n 5

calo

ries p

er

serv

ing)

;

Tota

l fat

, sat

urat

ed fa

t, an

d tra

ns fa

t (w

hen

grea

ter t

han

0.5

g pe

r se

rvin

g);

C

hole

ster

ol (w

hen

grea

ter t

han

2 m

g pe

r ser

ving

);

Sodi

um (w

hen

grea

ter t

han

5 m

g pe

r ser

ving

);

Tota

l car

bohy

drat

es (w

hen

grea

ter t

han

1 g

per s

ervi

ng);

D

ieta

ry fi

ber (

whe

n gr

eate

r tha

n 1

g pe

r ser

ving

);

Suga

rs (w

hen

grea

ter t

han

1 g

per s

ervi

ng);

Pr

otei

n (w

hen

grea

ter t

han

1 g

per s

ervi

ng; a

nd

V

itam

in A

, vita

min

C, c

alci

um, a

nd ir

on (w

hen

pres

ent a

t gre

ater

th

an 2

% o

f the

reco

mm

ende

d da

ily in

take

).

☐

☐

☐

G7.

1(a)

(1-3

) • Id

entif

icat

ion

- Doe

s the

ope

ratio

n ha

ve S

OPs

, pro

toco

ls, a

nd

reco

rd k

eepi

ng in

pla

ce e

nsur

ing

the

prop

er id

entif

icat

ion,

at a

ll tim

es, o

f eac

h co

ntai

ner o

f com

pone

nt, p

acka

ging

com

pone

nt, i

n-pr

oces

s mat

eria

l, an

d pr

oduc

t, in

clud

ing

the

follo

win

g?

Id

entit

y of

the

item

;

Bat

ch, l

ot, o

r con

trol n

umbe

r;

Stat

us (e

.g.,

quar

antin

ed, a

ppro

ved,

reca

lled,

reje

cted

).

☐

☐

☐

SAMPLE

G7.

1(b)

• Id

entif

icat

ion

- Doe

s the

ope

ratio

n ha

ve S

OPs

, pro

toco

ls, a

nd

reco

rd k

eepi

ng in

pla

ce e

nsur

ing

the

prop

er id

entif

icat

ion

and

hand

ling

of

prod

uct p

acka

ges t

hat a

re h

eld

in u

nlab

eled

con

ditio

n fo

r fut

ure

labe

ling

oper

atio

n, p

recl

udin

g m

isla

belin

g of

indi

vidu

al c

onta

iner

s, lo

ts, o

r bat

ches

?

Iden

tific

atio

n ne

ed n

ot b

e ap

plie

d to

eac

h in

divi

dual

con

tain

er b

ut m

ust b

e su

ffici

ent t

o de

term

ine

the

iden

tity

of th

e pr

oduc

t, qu

antit

y of

con

tent

s, an

d ba

tch,

lot,

or c

ontro

l num

ber o

f eac

h co

ntai

ner.

☐

☐

☐

G7.

1(c)

(1-2

) • Id

entif

icat

ion

- Doe

s the

ope

ratio

n ha

ve S

OPs

, pro

toco

ls, a

nd

reco

rd k

eepi

ng in

pla

ce e

nsur

ing

that

the

iden

tific

atio

n in

form

atio

n re

quire

d in

se

ctio

n 7.

1(a)

and

(b) h

as b

een

affix

ed to

the

indi

vidu

al c

onta

iner

or t

o an

ap

prop

riate

gro

upin

g of

con

tain

ers,

or a

ssig

ned

to th

e ro

om o

r oth

er d

efin

ed

phys

ical

loca

tion

of th

e co

ntai

ner(

s)?

☐

☐

☐

G7.

2(a)

• St

orag

e an

d ha

ndlin

g - D

oes t

he o

pera

tion

have

SO

Ps, p

roto

cols

, an

d re

cord

kee

ping

in p

lace

ens

urin

g th

at a

ll co

mpo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss m

ater

ials

, and

pro

duct

s are

, at a

ll tim

es, h

andl

ed,

stor

ed, a

nd d

istri

bute

d in

a m

anne

r to

avoi

d de

terio

ratio

n, p

reve

nt

cont

amin

atio

n, a

nd m

ix-u

ps?

Whe

re n

eces

sary

, are

app

ropr

iate

con

ditio

ns o

f te

mpe

ratu

re, h

umid

ity, a

nd li

ght e

stab

lishe

d an

d m

aint

aine

d so

that

the

iden

tity,

pur

ity, s

treng

th, a

nd c

ompo

sitio

n of

com

pone

nts,

in-p

roce

ss m

ater

ials

, an

d pr

oduc

ts a

re n

ot a

ffect

ed a

nd th

at a

dulte

ratio

n is

pre

vent

ed, a

s req

uire

d?

☐

☐

☐

G7.

2(b)

• St

orag

e an

d ha

ndlin

g - D

oes t

he o

pera

tion

have

SO

Ps, p

roto

cols

, an

d re

cord

kee

ping

in p

lace

ens

urin

g th

at a

ll co

ntai

ners

of c

ompo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss m

ater

ials

and

pro

duct

are

pro

perly

stor

ed

off t

he fl

oor a

nd su

itabl

y sp

aced

to p

erm

it cl

eani

ng a

nd in

spec

tion?

☐

☐

☐

G7.

2(c)

• St

orag

e an

d ha

ndlin

g - D

oes t

he o

pera

tion

have

SO

Ps, p

roto

cols

, an

d re

cord

kee

ping

in p

lace

ens

urin

g th

at a

ll co

mpo

nent

s, in

-pro

cess

mat

eria

ls,

and

prod

ucts

that

can

supp

ort t

he ra

pid

grow

th o

f mic

roor

gani

sms o

f pub

lic

heal

th si

gnifi

canc

e ar

e he

ld in

a m

anne

r tha

t pre

vent

s the

m fr

om b

ecom

ing

adul

tera

ted?

☐

☐

☐

G7.

2(d)

• St

orag

e an

d ha

ndlin

g - D

oes t

he o

pera

tion

have

SO

Ps, p

roto

cols

, an

d re

cord

kee

ping

in p

lace

ens

urin

g th

at a

ll la

bels

, lab

elin

g, c

anna

bis,

cann

abis

-der

ived

pro

duct

s, an

d ca

nnab

is w

aste

are

stor

ed in

a c

ontro

lled

acce

ss

area

?

☐

☐

☐

SAMPLE

G7.

2(e)

• St

orag

e an

d ha

ndlin

g - D

oes t

he o

pera

tion

have

SO

Ps, p

roto

cols

, an

d re

cord

kee

ping

in p

lace

ens

urin

g th

at a

ll co

mpo

nent

s, pa

ckag

ing

com

pone

nts,

and

prod

ucts

are

use

d or

dis

tribu

ted

in a

man

ner w

here

by th

e ol

dest

bat

ches

or l

ots a

re u

sed

or d

istri

bute

d fir

st?

Dev

iatio

n fro

m th

is

requ

irem

ent i

s per

mitt

ed if

such

dev

iatio

n is

tem

pora

ry a

nd a

ppro

pria

te.

☐

☐

☐

G7.

3(a)

(1-5

) • W

ithho

ldin

g m

ater

ials

from

use

or

dist

ribu

tion

- Doe

s the

m

anuf

actu

ring,

pac

kagi

ng, a

nd la

belin

g op

erat

ion

have

SO

Ps, p

roto

cols

, and

re

cord

kee

ping

in p

lace

ens

urin

g th

e ab

ility

to q

uara

ntin

e an

y lo

t, ba

tch,

or

othe

r por

tion

of c

ompo

nent

, pac

kagi

ng c

ompo

nent

, in-

proc

ess m

ater

ial,

or

prod

uct w

hose

suita

bilit

y fo

r use

or d

istri

butio

n is

in q

uest

ion,

to p

reve

nt it

s us

e an

d di

strib

utio

n pe

ndin

g di

spos

ition

by

qual

ity-c

ontro

l per

sonn

el,

incl

udin

g th

e fo

llow

ing?

New

ly re

ceiv

ed c

ompo

nent

s and

pac

kagi

ng c

ompo

nent

s for

use

in

man

ufac

turin

g, p

acka

ging

, and

/or l

abel

ing;

Bat

ches

new

ly c

ompl

eted

in p

rodu

ctio

n;

Pr

oduc

t ret

urne

d to

the

oper

atio

n fo

r any

reas

on;

C

ompo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss m

ater

ials

, or

prod

ucts

that

are

or m

ay b

e co

ntam

inat

ed o

r adu

ltera

ted;

Com

pone

nts,

pack

agin

g co

mpo

nent

s, in

-pro

cess

mat

eria

l or p

rodu

cts

that

are

und

er in

vest

igat

ion

by q

ualit

y-co

ntro

l per

sonn

el fo

r any

ot

her r

easo

n.

☐

☐

☐

G7.

3(b)

• W

ithho

ldin

g m

ater

ials

from

use

or

dist

ribu

tion

- Doe

s the

op

erat

ion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce e

nsur

ing

that

re

ject

ed c

ompo

nent

s, pa

ckag

ing

com

pone

nts,

in-p

roce

ss m

ater

ials

, fin

ishe

d pr

oduc

t, ca

nnab

is w

aste

, and

reje

cted

labe

ls a

nd la

belin

g (in

clud

ing

any

exce

ss

labe

ling

bear

ing

lot,

batc

h, o

r con

trol n

umbe

rs w

hich

is n

ot im

med

iate

ly

dest

roye

d af

ter p

acka

ging

ope

ratio

ns a

re c

ompl

ete)

will

be

appr

opria

tely

se

greg

ated

, con

trolle

d, a

nd h

eld

in a

con

trolle

d-ac

cess

are

a pe

ndin

g de

stru

ctio

n or

oth

er d

ispo

sal?

☐

☐

☐

G7.

3(c)

• W

ithho

ldin

g m

ater

ials

from

use

or

dist

ribu

tion

- Doe

s the

op

erat

ion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce e

nsur

ing

that

ca

nnab

is w

aste

(oth

er th

an c

anna

bis a

nd c

anna

bis-

deriv

ed p

rodu

ct th

at h

as

been

reje

cted

and

retu

rned

to th

e ve

ndor

) and

reje

cted

labe

ls a

nd o

ther

labe

ling

are

dest

roye

d in

a m

anne

r whi

ch p

reve

nts u

naut

horiz

ed u

se?

Is d

estru

ctio

n of

an

y ca

nnab

is w

aste

doc

umen

ted

and

witn

esse

d by

at l

east

two

wor

kers

, one

of

who

m m

ust b

e su

perv

isor

y, m

anag

eria

l, or

qua

lity-

cont

rol p

erso

nnel

, unl

ess

vide

o su

rvei

llanc

e is

use

d, in

whi

ch c

ase

only

one

wor

ker i

s nec

essa

ry, a

s re

quire

d? D

estru

ctio

n m

ay in

clud

e co

mpo

stin

g.

☐

☐

☐

SAMPLE

H8.

1(a)

• M

ater

ials

inve

ntor

y - D

oes t

he m

anuf

actu

ring,

pac

kagi

ng, l

abel

ing,

an

d ho

ldin

g op

erat

ion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng fo

r eac

h sh

ipm

ent o

f com

pone

nt, p

acka

ging

com

pone

nt, c

anna

bis,

and

cann

abis

-de

rived

pro

duct

rece

ived

from

ano

ther

com

pany

or i

ndiv

idua

l?

☐

☐

☐

H8.

1(b)

(1-2

) • M

ater

ials

inve

ntor

y - D

oes t

he m

anuf

actu

ring,

pac

kagi

ng,

labe

ling,

and

hol

ding

ope

ratio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

no

ting

the

iden

tity

of th

e re

ceiv

ed it

em, a

s app

licab

le to

the

item

; any

co

mpo

nent

num

ber o

r pro

duct

num

ber i

f suc

h ar

e in

use

be

the

supp

lier;

and

the

supp

lier o

r ven

dor f

rom

whi

ch th

e sh

ipm

ent w

as re

ceiv

ed?

☐

☐

☐

H8.

1(b)

(3-6

) • M

ater

ials

inve

ntor

y - D

oes t

he m

anuf

actu

ring,

pac

kagi

ng,

labe

ling,

and

hol

ding

ope

ratio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

ev

iden

ce n

otin

g th

e fo

llow

ing

info

rmat

ion?

The

orig

inal

cul

tivat

ion

oper

atio

n, p

roce

ssin

g op

erat

ion,

or

man

ufac

turin

g op

erat

ion,

if k

now

n an

d w

here

app

licab

le;

Th

e cu

ltiva

tion

oper

atio

n, p

roce

ssin

g op

erat

ion,

man

ufac

turin

g op

erat

ion,

or s

uppl

ier’

s bat

ch, l

ot o

r con

trol n

umbe

r, if

know

n an

d w

here

app

licab

le;

D

ate

of re

ceip

t; an

d

Ship

men

t del

iver

y m

etho

d, in

clud

ing

whe

re a

pplic

able

, the

nam

e of

th

e co

mm

erci

al o

r priv

ate

carr

ier.

☐

☐

☐

H8.

1(c)

(1) •

Mat

eria

ls in

vent

ory

- Doe

s the

man

ufac

turin

g, p

acka

ging

, and

la

belin

g op

erat

ion

have

SO

Ps a

nd p

roto

cols

, for

the

reco

rd k

eepi

ng o

r es

tabl

ishm

ent o

f cro

ss re

fere

nces

to o

ther

reco

rds s

uch

as m

anuf

actu

ring

batc

h re

cord

s inc

ludi

ng th

e ba

tch,

lot,

or o

ther

con

trol n

umbe

r ass

igne

d by

the

man

ufac

turin

g, p

acka

ging

, and

/or l

abel

ing

oper

atio

n to

the

ship

men

t?

☐

☐

☐

H8.

1(c)

(2) •

Mat

eria

ls in

vent

ory

- Doe

s the

man

ufac

turin

g, p

acka

ging

, and

la

belin

g op

erat

ion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng, o

r hav

e es

tabl

ishe

d cr

oss r

efer

ence

syst

ems t

o ot

her r

ecor

ds su

ch a

s man

ufac

turin

g ba

tch

reco

rds,

reco

rdin

g th

e in

spec

tion,

sam

plin

g, te

stin

g an

d ex

amin

atio

ns

perfo

rmed

on

the

batc

h or

lot,

and

the

conc

lusi

ons d

eriv

ed th

ere

from

, as

appl

icab

le to

the

scop

e of

the

oper

atio

n?

☐

☐

☐

SAMPLE

H8.

1(c)

(3) •

Mat

eria

ls in

vent

ory

- Doe

s the

man

ufac

turin

g, p

acka

ging

, and

la

belin

g op

erat

ion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng, o

r hav

e

esta

blis

hed

cros

s ref

eren

ce sy

stem

s to

othe

r rec

ords

such

as m

anuf

actu

ring

batc

h re

cord

s, re

cord

ing

all t

reat

men

t, re

proc

essi

ng, o

r oth

er d

evia

tion

perfo

rmed

by

the

oper

atio

n on

the

batc

h or

lot p

rior t

o us

e?

☐

☐

☐

H8.

1(c)

(4) •

Mat

eria

ls in

vent

ory

- Doe

s the

man

ufac

turin

g, p

acka

ging

, and

la

belin

g op

erat

ion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng, o

r hav

e es

tabl

ishe

d cr

oss r

efer

ence

syst

ems t

o ot

her r

ecor

ds su

ch a

s man

ufac

turin

g ba

tch

reco

rds,

reco

rdin

g th

e di

spos

ition

of t

he b

atch

or l

ot b

y qu

ality

-con

trol

pers

onne

l, in

clud

ing

the

date

and

sign

atur

e of

the

pers

on re

spon

sibl

e fo

r ap

prov

ing

or re

ject

ing

the

batc

h or

lot a

nd a

ny tr

eatm

ents

, rep

roce

ssin

g, o

r ot

her d

evia

tion

perfo

rmed

ther

eon?

☐

☐

☐

H8.

1(c)

(5)(

i-iii)

• M

ater

ials

inve

ntor

y - D

oes t

he m

anuf

actu

ring,

pac

kagi

ng,

and

labe

ling

oper

atio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

, or h

ave

esta

blis

hed

cros

s ref

eren

ce sy

stem

s to

othe

r rec

ords

such

as m

anuf

actu

ring

batc

h re

cord

s, no

ting

each

use

of t

he b

atch

or l

ot in

pro

duct

ion,

incl

udin

g th

e qu

antit

y us

ed, i

nclu

ding

uni

t of m

easu

re; n

ame

and

batc

h, lo

t or o

ther

con

trol

num

ber o

f the

pro

duct

bat

ch in

whi

ch th

e ba

tch

or lo

t is u

sed,

and

the

initi

als

of th

e pe

rson

(s) r

espo

nsib

le fo

r rem

ovin

g fro

m st

orag

e th

e ne

cess

ary

quan

tity

for u

se in

the

desi

gnat

ed b

atch

?

☐

☐

☐

H8.

1(c)

(6)(

i-iii)

• M

ater

ials

inve

ntor

y - D

oes t

he m

anuf

actu

ring,

pac

kagi

ng,

and

labe

ling

oper

atio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

, or h

ave

esta

blis

hed

cros

s ref

eren

ce sy

stem

s to

othe

r rec

ords

such

as m

anuf

actu

ring

batc

h re

cord

s, no

ting

a re

cord

of a

ny p

ortio

n of

the

batc

h or

lot r

etur

ned

from

pr

oduc

tion

to st

orag

e in

clud

ing

the

quan

tity

retu

rned

; uni

t of m

easu

re; n

ame

and

batc

h, lo

t, or

oth

er c

ontro

l num

ber o

f the

bat

ch o

r lot

from

whi

ch th

e po

rtion

is re

turn

ed; a

nd th

e in

itial

s of t

he p

erso

ns re

spon

sibl

e fo

r ver

ifyin

g th

e qu

antit

y re

turn

ed?

☐

☐

☐

H8.

1(c)

(7)(

i-iii)

• M

ater

ials

inve

ntor

y - D

oes t

he m

anuf

actu

ring,

pac

kagi

ng,

and

labe

ling

oper

atio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

, or h

ave

esta

blis

hed

cros

s ref

eren

ce sy

stem

s to

othe

r rec

ords

such

as m

anuf

actu

ring

batc

h re

cord

s, in

clud

ing

a re

cord

of a

ny p

ortio

n of

the

batc

h or

lot d

ispo

sed

of

from

stor

age,

incl

udin

g th

e qu

antit

y, u

nit o

f mea

sure

, rea

son,

and

per

sons

re

spon

sible

for m

easu

ring

the

quan

tity?

☐

☐

☐

SAMPLE

H8.

2(a)

• D

istr

ibut

ed m

ater

ials

- D

oes t

he m

anuf

actu

ring,

pac

kagi

ng,

labe

ling,

and

hol

ding

ope

ratio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

for

each

bat

ch o

r lot

of c

anna

bis o

r can

nabi

s-de

rived

pro

duct

dis

tribu

ted

by th

e op

erat

ion?

☐

☐

☐

H8.

2(b)

(1) •

Dis

trib

uted

mat

eria

ls -

Doe

s the

man

ufac

turin

g, p

acka

ging

, la

belin

g, a

nd h

oldi

ng o

pera

tion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng th

at

incl

udes

the

iden

tity

of th

e ca

nnab

is o

r can

nabi

s-de

rived

pro

duct

and

any

item

co

de o

r pro

duct

num

ber,

if su

ch a

re in

use

by

the

man

ufac

turin

g, p

acka

ging

, la

belin

g, o

r hol

ding

ope

ratio

n?

☐

☐

☐

H8.

2(b)

(2)(

i-iv)

• D

istr

ibut

ed m

ater

ials

- D

oes t

he m

anuf

actu

ring,

pa

ckag

ing,

labe

ling,

and

hol

ding

ope

ratio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

ke

epin

g th

at in

clud

es a

reco

rd o

f eac

h di

strib

utio

n of

the

batc

h or

lot,

incl

udin

g th

e fo

llow

ing?

Qua

ntity

dis

tribu

ted,

incl

udin

g un

it of

mea

sure

;

Nam

e an

d ad

dres

s of e

ach

com

pany

or n

on-p

rofit

ent

ity to

whi

ch, o

r in

divi

dual

to w

hom

, the

bat

ch is

dis

tribu

ted,

unl

ess a

syst

em e

xist

s to

unam

bigu

ousl

y cr

oss-

refe

renc

e th

e na

me

to th

e co

rres

pond

ing

addr

ess m

aint

aine

d on

file

sepa

rate

ly;

Sh

ippi

ng m

etho

d by

whi

ch e

ach

ship

men

t is d

istri

bute

d, in

clud

ing

whe

re a

pplic

able

the

nam

e of

the

com

mer

cial

or p

rivat

e ca

rrie

r;

Initi

als o

f the

per

sons

resp

onsib

le fo

r rem

ovin

g fro

m st

orag

e th

e ne

cess

ary

quan

tity

for e

ach

ship

men

t. Ea

ch d

istri

butio

n m

ust b

e ve

rifie

d by

a se

cond

per

son

☐

☐

☐

H8.

2(b)

(3)(

i-iv)

• D

istr

ibut

ed m

ater

ials

- D

oes t

he m

anuf

actu

ring,

pa

ckag

ing,

labe

ling,

and

hol

ding

ope

ratio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

ke

epin

g th

at in

clud

es a

reco

rd o

f any

por

tion

of th

e ba

tch

or lo

t ret

urne

d to

st

orag

e, in

clud

ing

the

follo

win

g?

Q

uant

ity re

turn

ed, i

nclu

ding

the

unit

of m

easu

re;

C

ompa

ny, n

on-p

rofit

ent

ity, i

ndiv

idua

l, or

loca

tion

from

whi

ch th

e po

rtion

is re

turn

ed;

Sh

ipm

ent r

etur

n m

etho

d, in

clud

ing

whe

re a

pplic

able

the

nam

e of

the

com

mer

cial

or p

rivat

e ca

rrie

r;

Initi

als o

f the

per

son(

s) re

spon

sible

for v

erify

ing

the

quan

tity

retu

rned

.

☐

☐

☐

SAMPLE

H8.

2(c)

(1-4

) • D

istr

ibut

ed m

ater

ials

- D

oes t

he m

anuf

actu

ring,

pac

kagi

ng,

labe

ling,

and

hol

ding

ope

ratio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

, or

esta

blis

hed

the

abili

ty to

cro

ss re

fere

nce

to o

ther

reco

rds s

uch

as

man

ufac

turin

g ba

tch

reco

rds,

for t

he fo

llow

ing?

Bat

ch, l

ot, o

r oth

er c

ontro

l num

ber a

ssig

ned

by th

e m

anuf

actu

ring,

pa

ckag

ing,

and

/or l

abel

ing

oper

atio

n to

the

batc

h or

lot;

In

spec

tion,

sam

plin

g, te

stin

g, a

nd e

xam

inat

ions

per

form

ed o

n th

e ba

tch

or lo

t by

the

oper

atio

n, a

nd th

e co

nclu

sion

s der

ived

ther

e fro

m;

A

ny tr

eatm

ent,

repr

oces

sing

, or o

ther

dev

iatio

n pe

rform

ed o

n th

e ba

tch

or lo

t by

the

oper

atio

n pr

ior t

o di

strib

utio

n;

D

ispo

sitio

n of

the

batc

h or

lot b

y qu

ality

-con

trol p

erso

nnel

, in

clud

ing

the

date

and

the

sign

atur

e of

the

pers

on re

spon

sibl

e fo

r the

ap

prov

ing

the

batc

h or

lot f

or d

istri

butio

n; a

nd

Th

e da

te a

nd th

e si

gnat

ure

of th

e pe

rson

resp

onsib

le fo

r app

rovi

ng o

r re

ject

ing

ay tr

eatm

ent,

repr

oces

sing,

or o

ther

dev

iatio

n pe

rform

ed

ther

eon.

☐

☐

☐

H8.

4(a)

• R

econ

cilia

tion

- Doe

s the

ope

ratio

n ha

ve S

OPs

, pro

toco

ls, a

nd

reco

rd k

eepi

ng fo

r rec

ords

of r

ecei

pt, u

se o

r dis

tribu

tion,

retu

rn, a

nd d

ispos

al

of e

ach

batc

h or

lot o

f com

pone

nts,

pack

agin

g co

mpo

nent

s, ca

nnab

is o

r ca

nnab

is-d

eriv

ed p

rodu

cts t

o be

kep

t chr

onol

ogic

ally

, and

the

quan

titie

s mus

t be

reco

rded

with

an

appr

opria

te le

vel o

f pre

cisi

on?

☐

☐

☐

H8.

4(b)

• R

econ

cilia

tion

- Doe

s the

man

ufac

turin

g, p

acka

ging

, lab

elin

g, a

nd

hold

ing

oper

atio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

ens

urin

g th

at a

fter e

ach

batc

h or

lot i

s use

d or

dis

tribu

ted

a re

conc

iliat

ion

of th

e qu

antit

y re

ceiv

ed in

to st

orag

e ag

ains

t the

qua

ntity

use

d, d

istri

bute

d, re

turn

ed, a

nd/o

r di

spos

ed c

an b

e as

sess

ed?

Are

such

cal

cula

tions

per

form

ed b

y on

e pe

rson

and

in

depe

nden

tly v

erifi

ed b

y a

seco

nd p

erso

n, a

s req

uire

d?

☐

☐

☐

H8.

4(c)

• R

econ

cilia

tion

- Doe

s the

man

ufac

turin

g, p

acka

ging

, lab

elin

g, a

nd

hold

ing

oper

atio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

ens

urin

g th

at n

arro

w li

mits

are

est

ablis

hed,

bas

ed w

here

pos

sibl

e on

his

toric

al o

pera

ting

data

, for

the

amou

nt o

f allo

wed

var

iatio

n in

the

reco

ncili

atio

n?

☐

☐

☐

H8.

4(d)

• R

econ

cilia

tion

- Doe

s the

man

ufac

turin

g, p

acka

ging

, lab

elin

g, a

nd

hold

ing

oper

atio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

ens

urin

g th

at w

hen

a re

conc

iliat

ion

falls

out

side

the

allo

wed

lim

its, q

ualit

y-co

ntro

l pe

rson

nel w

ill c

ondu

ct a

n in

vest

igat

ion

to d

eter

min

e, to

the

exte

nt p

ossi

ble,

the

sour

ce o

f the

dis

crep

ancy

? T

he d

evia

tion

mus

t be

docu

men

ted,

exp

lain

ed, a

nd

appr

oved

by

qual

ity-c

ontro

l per

sonn

el.

☐

☐

☐

SAMPLE

H8.

5(a)

• R

ecor

d re

tent

ion

- Doe

s the

man

ufac

turin

g, p

acka

ging

, lab

elin

g,

and

hold

ing

oper

atio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

en

surin

g th

at, e

xcep

t as r

equi

red

in se

ctio

ns 8

.5(b

) and

(c),

the

oper

atio

n re

tain

s the

reco

rds r

equi

red

by th

is pa

rt fo

r a p

erio

d of

at l

east

thre

e ye

ars p

ast

date

of c

reat

ion

of th

e re

cord

, or o

ne y

ear p

ast t

he e

xpira

tion

date

of t

he re

late

d pr

oduc

t, w

hich

ever

is lo

nger

, as a

pplic

able

to th

e op

erat

ion?

☐

☐

☐

H8.

5(b)

• R

ecor

d re

tent

ion

- Doe

s the

man

ufac

turin

g, p

acka

ging

, lab

elin

g,

and

hold

ing

oper

atio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

en

surin

g th

at p

rodu

ct c

ompl

aint

reco

rds a

re re

tain

ed fo

r one

yea

r pas

t the

ex

pira

tion

date

of t

he b

atch

or l

ot a

ffec

ted,

or f

or o

ne y

ear p

ast t

he d

ate

of

rece

ipt o

f the

com

plai

nt, w

hich

ever

is lo

nger

?

☐

☐

☐

H8.

5(c)

• R

ecor

d re

tent

ion

- Doe

s the

man

ufac

turin

g, p

acka

ging

, lab

elin

g,

and

hold

ing

oper

atio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

en

surin

g th

at re

cord

s for

retu

rned

pro

duct

s ar

e re

tain

ed fo

r one

yea

r pas

t the

ex

pira

tion

date

of t

he b

atch

or l

ot a

ffec

ted,

or f

or o

ne y

ear p

ast t

he d

ate

of

rece

ipt o

f the

retu

rn, w

hich

ever

is lo

nger

?

☐

☐

☐

I9.1

(a) •

Com

plai

nt fi

les -

Doe

s the

man

ufac

turin

g, p

acka

ging

, lab

elin

g, a

nd

hold

ing

oper

atio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

de

scrib

ing

the

hand

ling

of p

rodu

ct c

ompl

aint

s rec

eive

d re

gard

ing

a ca

nnab

is o

r ca

nnab

is-d

eriv

ed p

rodu

ct?

☐

☐

☐

I9.1

(b)(

1-2)

• C

ompl

aint

file

s - D

oes t

he m

anuf

actu

ring,

pac

kagi

ng, l

abel

ing,

an

d ho

ldin

g op

erat

ion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng in

pla

ce

requ

iring

a q

ualif

ied

pers

on to

do

the

follo

win

g?

R

evie

w p

rodu

ct c

ompl

aint

s to

dete

rmin

e w

heth

er th

e pr

oduc

t co

mpl

aint

invo

lves

a p

ossib

le fa

ilure

of a

pro

duct

to m

eet a

ny o

f its

sp

ecifi

catio

ns, o

r any

oth

er re

quire

men

ts, i

nclu

ding

but

not

lim

ited

to

thos

e sp

ecifi

catio

ns a

nd o

ther

requ

irem

ents

that

, if n

ot m

et, m

ay

resu

lt in

a ri

sk o

f illn

ess o

r inj

ury;

and

Inve

stig

ate

any

prod

uct c

ompl

aint

that

invo

lves

a p

ossi

ble

failu

re o

f a

prod

uct t

o m

eet a

ny o

f its

spec

ifica

tions

, or a

ny o

ther

requ

irem

ents

of

this

par

t, in

clud

ing

but n

ot li

mite

d to

thos

e sp

ecifi

catio

ns a

nd

othe

r req

uire

men

ts th

at, i

f not

met

, may

resu

lt in

a ri

sk o

f illn

ess o

r in

jury

.

☐

☐

☐

SAMPLE

I9.1

(c) •

Com

plai

nt fi

les -

Doe

s the

man

ufac

turin

g, p

acka

ging

, lab

elin

g, a

nd

hold

ing

oper

atio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

ens

urin

g th

at q

ualit

y-co

ntro

l per

sonn

el re

view

and

app

rove

dec

isio

ns a

bout

whe

ther

to

inve

stig

ate

a pr

oduc

t com

plai

nt a

nd re

view

and

app

rove

the

findi

ngs a

nd

follo

w-u

p ac

tion

of a

ny in

vest

igat

ion

perfo

rmed

?

☐

☐

☐

I9.1

(d) •

Com

plai

nt fi

les -

Doe

s the

man

ufac

turin

g, p

acka

ging

, lab

elin

g, a

nd

hold

ing

oper

atio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

ens

urin

g th

e re

view

and

inve

stig

atio

n of

the

prod

uct c

ompl

aint

, and

the

revi

ew b

y qu

ality

-con

trol p

erso

nnel

abo

ut w

heth

er to

inve

stig

ate

a pr

oduc

t com

plai

nt,

and

the

findi

ngs a

nd fo

llow

-up

actio

n of

any

inve

stig

atio

n pe

rform

ed, e

xten

ds

to a

ll re

late

d ba

tche

s and

rele

vant

reco

rds?

Rel

ated

bat

ches

may

incl

ude,

but

ar

e no

t lim

ited

to, b

atch

es o

f the

sam

e pr

oduc

t, ot

her b

atch

es p

roce

ssed

on

the

sam

e eq

uipm

ent o

r dur

ing

the

sam

e tim

e pe

riod,

or o

ther

bat

ches

pro

duce

d us

ing

the

sam

e ba

tche

s or l

ots o

f com

pone

nts o

r pac

kagi

ng c

ompo

nent

s.

☐

☐

☐

I9.1

(e) •

Com

plai

nt fi

les -

Doe

s the

man

ufac

turin

g, p

acka

ging

, lab

elin

g, a

nd

hold

ing

oper

atio

n ha

ve a

writ

ten

reco

rd o

f the

com

plai

nt(s

) and

whe

re

appl

icab

le it

s inv

estig

atio

n re

port,

to in

clud

e th

e fo

llow

ing

info

rmat

ion?

Iden

tity

of th

e pr

oduc

t;

Bat

ch, l

ot o

r oth

er c

ontro

l num

ber o

f the

pro

duct

;

Dat

e th

e co

mpl

aint

was

rece

ived

and

the

nam

e, a

ddre

ss, o

r tel

epho

ne

num

ber o

f the

com

plai

nant

, if a

vaila

ble;

Nat

ure

of th

e co

mpl

aint

incl

udin

g, if

kno

wn,

how

the

prod

uct w

as

used

Nam

es o

f per

sonn

el w

ho d

o th

e fo

llow

ing;

revi

ew a

nd a

ppro

ve th

e de

cisi

on a

bout

whe

ther

to in

vest

igat

e a

prod

uct c

ompl

aint

s;

inve

stig

ate

the

com

plai

nt; a

nd re

view

and

app

rove

the

findi

ngs a

nd

follo

w-u

p ac

tion

of a

ny in

vest

igat

ion

perfo

rmed

;

Find

ings

of t

he in

vest

igat

ion

and

follo

w-u

p ac

tion

take

n w

hen

an

inve

stig

atio

n is

per

form

ed; a

nd

R

espo

nse

to th

e co

mpl

aina

nt, i

f app

licab

le.

☐

☐

☐

SAMPLE

I9.1

(f) •

Com

plai

nt fi

les -

Doe

s the

man

ufac

turin

g, p

acka

ging

, lab

elin

g, a

nd

hold

ing

oper

atio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

for a

pr

oduc

t com

plai

nt th

at in

clud

es a

repo

rt of

an

adve

rse

even

t? F

or p

urpo

ses o

f th

is se

ctio

n, a

n ad

vers

e ev

ent i

s a h

ealth

-rel

ated

eve

nt a

ssoc

iate

d w

ith u

se o

f a

prod

uct t

hat i

s und

esira

ble,

and

that

is u

nexp

ecte

d or

unu

sual

. The

pro

cedu

re

mus

t add

ress

whe

ther

the

adve

rse

even

t req

uire

s the

follo

win

g:

R

epor

ting

to a

ny p

ublic

hea

lth a

utho

rity;

Rep

ortin

g to

the

phys

icia

n of

reco

rd fo

r the

indi

vidu

al re

porte

d to

ha

ve e

xper

ienc

ed th

e ad

vers

e ev

ent,

if kn

own;

and

Prod

uct r

ecal

l.

☐

☐

☐

I9.2

(a) •

Ret

urne

d pr

oduc

ts -

Doe

s the

man

ufac

turin

g, p

acka

ging

, lab

elin

g,

and

hold

ing

oper

atio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

de

scrib

ing

the

rece

ipt,

hand

ling,

and

dis

posi

tion

of re

turn

ed c

anna

bis o

r ca

nnab

is-d

eriv

ed p

rodu

cts?

☐

☐

☐

I9.2

(b) •

Ret

urne

d pr

oduc

ts -

Doe

s the

man

ufac

turin

g, p

acka

ging

, lab

elin

g,

and

hold

ing

oper

atio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

en

surin

g th

at re

turn

ed p

rodu

cts a

re p

rope

rly id

entif

ied

as su

ch a

nd q

uara

ntin

ed

upon

rece

ipt?

☐

☐

☐

I9.2

(c) •

Ret

urne

d pr

oduc

ts -

Doe

s the

man

ufac

turin

g, p

acka

ging

, lab

elin

g,

and

hold

ing

oper

atio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

en

surin

g re

turn

ed p

rodu

ct is

revi

ewed

and

app

rove

d or

reje

cted

by

qual

ity-

cont

rol p

erso

nnel

?

☐

☐

☐

I9.2

(d) •

Ret

urne

d pr

oduc

ts -

Doe

s the

man

ufac

turin

g, p

acka

ging

, lab

elin

g,

and

hold

ing

oper

atio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

en

surin

g th

at if

the

cond

ition

s und

er w

hich

retu

rned

pro

duct

has

bee

n he

ld,

stor

ed, o

r shi

pped

bef

ore

or d

urin

g its

retu

rn, o

r if t

he c

ondi

tion

of th

e pr

oduc

t, its

con

tain

ers,

or la

belin

g, a

s a re

sult

of st

orag

e or

ship

ping

, cas

ts d

oubt

on

the

iden

tity,

pur

ity, s

treng

th, c

ompo

sitio

n, o

r fre

edom

from

con

tam

inat

ion

or

adul

tera

tion

of th

e pr

oduc

t, th

e re

turn

ed p

rodu

ct sh

all b

e re

ject

ed u

nles

s ex

amin

atio

n, te

stin

g, o

r oth

er in

vest

igat

ions

pro

ve th

e pr

oduc

t mee

ts

appr

opria

te st

anda

rds o

f ide

ntity

, pur

ity, s

treng

th, a

nd c

ompo

sitio

n an

d its

fre

edom

from

con

tam

inat

ion

or a

dulte

ratio

n?

☐

☐

☐

SAMPLE

I9.2

(e) •

Ret

urne

d pr

oduc

ts -

Doe

s the

man

ufac

turin

g, p

acka

ging

, lab

elin

g,

and

hold

ing

oper

atio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

en

surin

g th

at if

the

reas

on a

pro

duct

is re

turn

ed im

plic

ates

ass

ocia

ted

batc

hes,

an a

ppro

pria

te in

vest

igat

ion

is c

ondu

cted

that

ext

ends

to a

ll re

late

d ba

tche

s and

re

leva

nt re

cord

s? R

elat

ed b

atch

es m

ay in

clud

e, b

ut a

re n

ot li

mite

d to

, bat

ches

of

the

sam

e pr

oduc

t, ot

her b

atch

es p

roce

ssed

on

the

sam

e eq

uipm

ent o

r dur

ing

the

sam

e tim

e pe

riod,

or o

ther

bat

ches

pro

duce

d us

ing

the

sam

e co

mpo

nent

s or

pack

agin

g co

mpo

nent

s.

☐

☐

☐

I9.2

(f) •

Ret

urne

d pr

oduc

ts -

Doe

s the

man

ufac

turin

g, p

acka

ging

, lab

elin

g,

and

hold

ing

oper

atio

n ha

ve S

OPs

, pro

toco

ls, a

nd re

cord

kee

ping

in p

lace

en

surin

g th

e de

stru

ctio

n, a

s per

sect

ion

7.3(

c), o

f rej

ecte

d re

turn

ed p

rodu

ct

retu

rned

to th

e op

erat

ion?

☐

☐

☐

I9.2

(g)(

1-10

) • R

etur

ned

prod

ucts

- D

oes t

he m

anuf

actu

ring,

pac

kagi

ng,

labe

ling,

and

hol

ding

ope

ratio

n ha

ve a

writ

ten

reco

rd o

f all

retu

rns a

nd, w

here

ap

plic

able

, its

inve

stig

atio

n, in

clud

ing

the

follo

win

g?

Id

entit

y of

pro

duct

;

Bat

ch, l

ot, o

r oth

er c

ontro

l num

ber o

f the

pro

duct

Dat

e th

e re

turn

ed p

rodu

ct w

as re

ceiv

ed;

N

ame

and

addr

ess f

rom

whi

ch it

was

retu

rned

and

the

mea

ns b

y w

hich

it w

as re

turn

ed;

R

easo

n fo

r the

retu

rn;

R

esul

ts o

f any

test

s or e

xam

inat

ion

cond

ucte

d on

the

retu

rned

pr

oduc

t or o

n re

late

d ba

tche

s, if

any;

Find

ings

of t

he in

vest

igat

ion

and

follo

w-u

p ac

tion

take

n w

hen

an

inve

stig

atio

n is

per

form

ed;

A

ny re

proc

essi

ng p

erfo

rmed

on

the

retu

rned

pro

duct

;

The

ultim

ate

disp

ositi

on o

f the

retu

rned

pro

duct

and

the

date

of

disp

ositi

on; a

nd

N

ames

of t

he q

ualit

y-co

ntro

l per

sonn

el w

ho d

o th

e fo

llow

ing:

◦

Rev

iew

the

reas

on fo

r the

pro

duct

retu

rn;

◦ R

evie

w a

nd a

ppro

ve a

ny re

proc

essi

ng, a

s app

licab

le, a

nd

◦ R

evie

w a

nd a

ppro

ve th

e fin

ding

s and

follo

w-u

p ac

tion

of

any

inve

stig

atio

n pe

rform

ed.

☐

☐

☐

SAMPLE

I9.3

(a) •

Rec

all p

roce

dure

s - D

oes t

he m

anuf

actu

ring,

pac

kagi

ng, l

abel

ing,

an

d ho

ldin

g op

erat

ion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng e

stabl

ishi

ng a

pr

oced

ure

for r

ecal

ling

a pr

oduc

t tha

t has

bee

n sh

own

to p

rese

nt a

reas

onab

le

or re

mot

e pr

obab

ility

that

the

use

of th

e pr

oduc

t will

cau

se se

rious

adv

erse

he

alth

con

sequ

ence

s or c

ould

cau

se te

mpo

rary

or m

edic

ally

reve

rsib

le a

dver

se

heal

th c

onse

quen

ces?

Doe

s thi

s pro

cedu

re in

clud

e th

e fo

llow

ing,

as r

equi

red?

Fact

ors w

hich

nec

essi

tate

a re

call;

Pers

onne

l res

pons

ible

for a

reca

ll; a

nd

N

otifi

catio

n pr

otoc

ols.

☐

☐

☐

I9.3

(b) •

Rec

all p

roce

dure

s - D

oes t

he m

anuf

actu

ring,

pac

kagi

ng, l

abel

ing,

an

d ho

ldin

g op

erat

ion

have

SO

Ps, p

roto

cols

, and

reco

rd k

eepi

ng e

stabl

ishi

ng a

pr

oced

ure

for c

omm

unic

atin

g a

reca

ll of

pro

duct

dis

tribu

ted

by th

e op

erat

ion?

D

oes t

his p

roce

dure

incl

ude

the

follo

win

g, a

s req

uire

d?

A

mec

hani

sm to

con

tact

all

cust

omer

s tha

t hav

e, o

r cou

ld h

ave,

ob

tain

ed th

e pr

oduc

t fro

m th

e op

erat

ion;

A m

echa

nism

to c

onta

ct th

e ve

ndor

that

supp

lied

the

reca

lled

prod

uct t

o th

e op

erat

ion,

if a

pplic

able

;

Inst

ruct

ions

for t

he re

turn

or d

estru

ctio

n of

any

reca

lled

prod

uct b

y cu

stom

ers;

Inst

ruct

ions

for c

ontra

ctin

g th

e re

leva

nt m

anuf

actu

ring,

pac

kagi

ng,

labe

ling,

and

/or h

oldi

ng o

pera

tions

; and

Com

mun

icat

ion

and

outre

ach

via

med

ia, a

s nec

essa

ry a

nd

appr

opria

te.

☐

☐

☐

*Not

requ

ired

by A

HPA

doc

umen

t, no

t nec

essa

rily

an a

udit

poin

t. SAMPLE

IT

EM

S N

EED

ED

FO

R C

OM

PLI

AN

CE

A1.

1 • S

ubje

ct o

pera

tions

– Is

this

ope

ratio

n su

bjec

t to

stat

e an

d/or

loca

l ov

ersi

ght?

*

☐

☐

☐

A1.

2 • O

ther

stat

utor

y pr

ovis

ions

and

reg

ulat

ions

– Is

the

labo

rato

ry

oper

atio

n pr

esen

tly c

ompl

iant

with

all

othe

r app

licab

le st

atut

ory

prov

isio

ns

and

regu

latio

ns re

late

d to

can

nabi

s lab

orat

ory

oper

atio

ns in

the

juris

dict

ion

in

whi

ch th

is p

art a

pplie

s, an

d re

late

d to

all

othe

r bus

ines

s act

iviti

es u

nder

take

n in

con

duct

ing

a la

bora

tory

ope

ratio

n?

☐

☐

☐

B2.

1(b)

(1) •

Sco

pe o

f Lab

orat

ory

func

tions

– D

oes t

he o

pera

tion

have

st

anda

rdiz

ed p

roto

cols

, pro

cedu

res,

and

repo

rts (e

.g.,

SOPs

, wor

k in

stru

ctio

ns,

etc.

) for

ana

lytic

al te

stin

g of

can

nabi

s?*

☐

☐

☐

B2.

1(b)

(2)(

i-iv)

• Sc

ope

of L

abor

ator

y fu

nctio

ns –

Doe

s the

ope

ratio

n ha

ve

stan

dard

ized

pro

toco

ls, p

roce

dure

s, an

d re

ports

(i.e

., SO

Ps, w

ork

inst

ruct

ions

, et

c.) f

or a

naly

tical

test

ing

of c

anna

bis f

or p

urity

(mic

robi

olog

ical

org

anis

ms,

pest

icid

es, h

eavy

met

als,

solv

ents

, for

eign

mat

ter)

?*

☐

☐

☐

B2.

1(b)

(3)(

i-ii)

• Sco

pe o

f Lab

orat

ory

func

tions

– D

oes t

he o

pera

tion

have

st

anda

rdiz

ed p

roto

cols

, pro

cedu

res,

and

repo

rts (i

.e.,

SOPs

, wor

k in

stru

ctio

ns,

etc.

) for

ana

lytic

al te

stin

g of

can

nabi

s for

pot

ency

(can

nabi

noid

con

tent

, te

rpen

oid

cont

ent)?

*

☐

☐

☐

SAMPLE

IT

EM

S N

EED

ED

FO

R C

OM

PLI

AN

CE

B2.

1(b)

(4) •

Sco

pe o

f Lab

orat

ory

func

tions

– D

oes t

he o

pera

tion

have

st

anda

rdiz

ed p

roto

cols

, pro

cedu

res,

and

repo

rts (i

.e.,

SOPs

, wor

k in

stru

ctio

ns,

etc.

) for

ana

lytic

al te

stin

g of

can

nabi

s for

oth

er q

ualit

y fa

ctor

s (%

wat

er

cont

ent,

oil c

onte

nt, a

sh)?

*

☐

☐

☐

B2.

1(c)

(1) •

Can

nabi

s-de

rive

d pr

oduc

t ana

lysi

s – D

oes t

he la

bora

tory

hav

e st

anda

rdiz

ed p

roto

cols

, pro

cedu

res,

and

repo

rts fo

r ana

lytic

al te

stin

g of

ca

nnab

is-d

eriv

ed p

rodu

cts?

*

☐

☐

☐

B2.

1(c)

(2) •

Can

nabi

s-de

rive

d pr

oduc

t ana

lysi

s – D

oes t

he la

bora

tory

hav

e st

anda

rdiz

ed p

roto

cols

, pro

cedu

res,

and

repo

rts fo

r ana

lytic

al te

stin

g of

ca

nnab

is-d

eriv

ed p

rodu

cts f

or d

eter

min

atio

n of

any

fact

or o

f a p

rodu

ct’s

co

mpo

sitio

n or

nut

ritio

nal c

onte

nt?*

☐

☐

☐

B2.

1(d)

(1) •

SO

Ps fo

r ot

her

test

s and

exa

min

atio

n –

Doe

s the

labo

rato

ry

have

stan

dard

ized

pro

toco

ls, p

roce

dure

s, an

d re

ports

for g

ross

org

anol

eptic

an

alys

is?*

☐

☐

☐

B2.

1(d)

(2) •

SO

Ps fo

r te

sts a

nd e

xam

inat

ion

– D

oes t

he la

bora

tory

hav

e st

anda

rdiz

ed p

roto

cols

, pro

cedu

res,

and

repo

rts fo

r mac

rosc

opic

?*

☐

☐

☐

B2.

1(d)

(3) •

SO

Ps fo

r te

sts a

nd e

xam

inat

ion

– D

oes t

he la

bora

tory

hav

e st

anda

rdiz

ed p

roto

cols

, pro

cedu

res,

and

repo

rts fo

r mic

rosc

opic

?*

☐

☐

☐

B2.

1(d)

(4) •

SO

Ps fo

r te

sts a

nd e

xam

inat

ion

– D

oes t

he la

bora

tory

hav

e st

anda

rdiz

ed p

roto

cols

, pro

cedu

res,

and

repo

rts fo

r che

mic

al a

naly

sis?

* ☐

☐

☐

B2.

1(d)

(5) •

SO

Ps fo

r te

sts a

nd e

xam

inat

ion

– D

oes t

he la

bora

tory

hav

e st

anda

rdiz

ed p

roto

cols

, pro

cedu

res,

and

repo

rts fo

r gen

etic

ana

lysi

s?*

☐

☐

☐

B2.

1(d)

(6) •

SO

Ps fo

r te

sts a

nd e

xam

inat

ion

– D

oes t

he la

bora

tory

hav

e st

anda

rdiz

ed p

roto

cols

, pro

cedu

res,

and

repo

rts fo

r oth

er sc

ient

ifica

lly v

alid

m

etho

ds?*

☐

☐

☐

B3.

1(a)

(1-2

) • P

erso

nnel

trai

ning

– D

oes e

ach

pers

on e

ngag

ed in

a la

bora

tory

op

erat

ion

have

edu

catio

n, tr

aini

ng, e

xper

ienc

e, a

nd su

perv

isio

n, o

r any

co

mbi

natio

n th

ereo

f, to

ena

ble

that

per

son

to p

erfo

rm a

ll as

sign

ed fu

nctio

ns?

☐

☐

☐

B3.

1(a)

(1-2

) • P

erso

nnel

trai

ning

– Is

the

leve

l of e

duca

tion

and

train

ing

docu

men

ted

or k

now

n fo

r dire

ctor

s, m

anag

ers,

and

inst

rum

ent o

pera

tors

?*

☐

☐

☐

B3.

1(b)

• Pe

rson

nel t

rain

ing

– D

oes t

he la

bora

tory

pro

vide

all

empl

oyee

s w

ith tr

aini

ngs,

and

docu

men

t atte

ndan

ce a

t tra

inin

gs fo

r eac

h em

ploy

ee?

☐

☐

☐

B3.

1(b)

(1) •

Per

sonn

el tr

aini

ng –

Doe

s the

labo

rato

ry p

rovi

de a

ll em

ploy

ees

with

Inst

ruct

ions

rega

rdin

g re

gula

tory

insp

ectio

n pr

epar

edne

ss?

☐

☐

☐

SAMPLE

IT

EM

S N

EED

ED

FO

R C

OM

PLI

AN

CE

B3.

1(b)

(1) •

Per

sonn

el tr

aini

ng –

Doe

s the

labo

rato

ry p

rovi

de a

ll em

ploy

ees

with

inst

ruct

ions

rega

rdin

g la

w-e

nfor

cem

ent i

nter

actio

ns?

☐

☐

☐

B3.

1(b)

(2) •

Per

sonn

el tr

aini

ng –

Doe

s the

labo

rato

ry p

rovi

de a

ll em

ploy

ees

with

inst

ruct

ion

on U

.S. f

eder

al la

ws,

regu

latio

ns, a

nd p

olic

ies r

elat

ing

to

indi

vidu

als e

mpl

oyed

in th

ese

oper

atio

ns, a

nd th

e im

plic

atio

ns o

f the

se fo

r su

ch e

mpl

oyee

s?

☐

☐

☐

B3.

1(b)

• Pe

rson

nel t

rain

ing

– D

oes t

he la

bora

tory

pro

vide

all

empl

oyee

s w

ith sa

fety

sem

inar

s and

/or a

nnua

l ref

resh

er tr

aini

ngs f

or e

mpl

oyee

con

duct

w

ithin

lab

wor

kspa

ce (

e.g.

, che

mic

al w

aste

han

dlin

g)?*

☐

☐

☐

D4.

1(a)

(1)(

i) • P

hysi

cal f

acili

ties –

Doe

s the

ope

ratio

n ha

ve e

vide

nce

that

it

oper

ates

in a

dher

ence

with

any

regu

latio

n in

the

juris

dict

ion

it op

erat

es fo

r lo

catio

ns a

nd z

onin

g fo

r all

type

of o

pera

tions

at t

he fa

cilit

y?

☐

☐

☐

D4.

1(a)

(1)(

ii) •

Phys

ical

faci

litie

s – D

oes t

he o

pera

tion

have

evi

denc

e th

at it

op

erat

es in

adh

eren

ce w

ith a

ny re

gula

tion

in th

e ju

risdi

ctio

n it

oper

ates

for

busi

ness

hou

rs?

☐

☐

☐

D4.

1(a)

(1)(

iii) •

Phy

sica

l fac

ilitie

s – D

oes t

he o

pera

tion

have

evi

denc

e th

at it

op

erat

es in

adh

eren

ce w

ith a

ny re

gula

tion

in th

e ju

risdi

ctio

n it

oper

ates

for

park

ing?

☐

☐

☐

D4.

1(a)

(1)(

iv) •

Phy

sica

l fac

ilitie

s – D

oes t

he o

pera

tion

have

evi

denc

e th

at it

op

erat

es in

adh

eren

ce w

ith a

ny re

gula

tion

in th

e ju

risdi

ctio

n it

oper

ates

for

driv

e-th

roug

h se

rvic

es?

☐

☐

☐

D4.

1(a)

(1)(

v) •

Phys

ical

faci

litie

s – D

oes t

he o

pera

tion

have

evi

denc

e th

at it

op

erat

es in

adh

eren

ce w

ith a

ny re

gula

tion

in th

e ju

risdi

ctio

n it

oper

ates

for

sign

age?

☐

☐

☐

D4.

1(a)

(2) •

Phy

sica

l fac

ilitie

s – D

oes t

he la

bora

tory

hav

e ev

iden

ce o

f bei

ng

mai

ntai

ned

in a

cle

an a

nd o

rder

ly fa

shio

n?

☐

☐

☐

D4.

1(a)

(3) •

Phy

sica

l fac

ilitie

s – Is

the

labo

rato

ry e

quip

ped

with

such

ute

nsils

as

are

nec

essa

ry to

con

duct

all

oper

atio

ns th

at o

ccur

at t

he fa

cilit

y?

☐

☐

☐

D4.

1(a)

(4) •

Phy

sica

l fac

ilitie

s – D

oes t

he la

bora

tory

pro

vide

ade

quat

e sp

ace

for o

pera

tions

, sam

ple

stor

age,

and

doc

umen

t sto

rage

? ☐

☐

☐

B4.

2(a)

• Se

curi

ty –

Doe

s the

ope

ratio

n ha

ve e

vide

nce

that

it h

as e

stab

lishe

d an

d ad

here

s to

such

secu

rity

proc

edur

es a

s pro

vide

d by

regu

latio

n in

the

ju

risdi

ctio

n in

whi

ch th

is p

art a

pplie

s?

☐

☐

☐

SAMPLE

IT

EM

S N

EED

ED

FO

R C

OM

PLI

AN

CE

B4.

2(b)

(1) •

Sec

urity

– D

oes t

he o

pera

tion

prov

ide

addi

tiona

l sec

urity

as

need

ed to

pro

tect

em

ploy

ees d

urin

g w

orki

ng h

ours

and

in a

man

ner

appr

opria

te fo

r the

com

mun

ity w

here

it o

pera

tes?

☐

☐

☐

B4.

2(b)

(2) •

Sec

urity

– D

oes t

he fa

cilit

y pr

ovid

e tra

inin

g to

mak

e al

l em

ploy

ees a

war

e of

the

oper

atio

n’s s

ecur

ity p

roce

dure

s, an

d ea

ch in

divi

dual

em

ploy

ee’s

secu

rity

role

s and

resp

onsib

ilitie

s?

☐

☐

☐

B4.

2(c)

(1) •

Sec

urity

– D

oes t

he o

pera

tion

have

one

or m

ore

cont

rolle

d ac

cess

ar

eas f

or th

e st

orag

e of

can

nabi

s and

can

nabi

s-de

rived

test

sam

ples

? ☐

☐

☐

B4.

2(c)

(2) •

Sec

urity

– D

oes t

he o

pera

tion

have

one

or m

ore

cont

rolle

d ac

cess

ar

eas f

or th

e st

orag

e of

can

nabi

s was

te?

☐

☐

☐

B4.

2(c)

(3) •

Sec

urity

– D

oes t

he o

pera

tion

have

one

or m

ore

cont

rolle

d ac

cess

ar

eas f

or th

e st

orag

e of

refe

renc

e st

anda

rds f

or a

naly

sis o

f can

nabi

noid

s?

☐

☐

☐

B4.

2(c)

(4) •

Sec

urity

– D

oes t

he o

pera

tion

have

one

or m

ore

cont

rolle

d ac

cess

ar

eas f

or th

e st

orag

e of

any

oth

er c

ontro

lled

subs

tanc

es?

☐

☐

☐

D4.

2(d)

• Se

curi

ty –

Doe

s the

ope

ratio

n lim

it ac

cess

to c

ontro

lled

area

s by

lock

s, el

ectro

nic

badg

e re

ader

s, bi

omet

ric id

entif

iers

or o

ther

mea

ns?

☐

☐

☐

D4.

2(e)

• Se

curi

ty –

Are

app

ropr

iate

step

s tak

en to

ens

ure

acce

ss p

rivile

ges t

o th

e la

bora

tory

faci

lity

and

to c

ontro

lled

acce

ss a

reas

, as a

pplic

able

, are

re

voke

d fo

r per

sonn

el w

ho a

re n

o lo

nger

em

ploy

ed b

y th

e op

erat

ion?

☐

☐

☐

D4.

2(f)

• Se

curi

ty D

ocum

enta

tion

– A

re th

e pr

oced

ures

for s

ecur

ity

docu

men

ted

in a

writ

ten

form

at a

cces

sibl

e to

em

ploy

ees?

☐

☐

☐

E5.

1(a)

• Sa

mpl

e re

ceip

t – D

oes t

he o

pera

tion

docu

men

t and

trac

k sa

mpl

es

take

n fro

m a

ny c

ompl

iant

bus

ines

s or c

olle

cted

on

beha

lf of

thos

e en

titie

s?*

☐

☐

☐

E5.

1(b)

(1) •

Sam

ple

rece

ipt –

Doe

s the

ope

ratio

n ha

ve e

stab

lishe

d an

d

impl

emen

ted

polic

ies f

or c

olle

ctin

g te

st sa

mpl

es in

a m

anne

r tha

t ens

ures

that

th

e te

st sa

mpl

e ac

cura

tely

repr

esen

ts th

e m

ater

ial b

eing

sam

pled

?

☐

☐

☐

E5.

1(b)

(1) •

Sam

ple

rece

ipt –

Doe

s the

ope

ratio

n ha

ve e

stab

lishe

d an

d

impl

emen

ted

polic

ies f

or o

ther

par

amet

ers a

ffect

ing

sam

ple

prep

arat

ion,

do

cum

enta

tion,

and

tran

spor

t?

☐

☐

☐

E5.

1(b)

(2)(

i) • S

ampl

e re

ceip

t – D

oes t

he o

pera

tion’

s pol

icy

cont

ain

the

acce

pted

test

sam

ple

type

s?

☐

☐

☐

SAMPLE

IT

EM

S N

EED

ED

FO

R C

OM

PLI

AN

CE

E5.

1(b)

(2)(

ii) •

Sam

ple

rece

ipt –

Doe

s the

ope

ratio

n’s p

olic

y co

ntai

n th

e ac

cept

ed m

inim

um te

st sa

mpl

e si

ze?

☐

☐

☐

E5.

1(b)

(2)(

iii) •

Sam

ple

rece

ipt –

Doe

s the

ope

ratio

n’s p

olic

y co

ntai

n th

e in

form

atio

n on

the

reco

mm

ende

d te

st sa

mpl

e co

ntai

ner?

☐

☐

☐

E5.

1(b)

(2)(

iv) •

Sam

ple

rece

ipt –

Doe

s the

ope

ratio

n’s p

olic

y co

ntai

n in

form

atio

n on

test

sam

ple

labe

ling?

☐

☐

☐

E5.

1(b)

(2)(

v) •

Sam

ple

rece

ipt –

Doe

s the

ope

ratio

n’s p

olic

y co

ntai

n in

form

atio

n on

app

ropr

iate

tran

spor

t and

stor

age

cond

ition

s, su

ch a

s re

frige

ratio

n if

requ

ired?

☐

☐

☐

E5.

1(b)

(2)(

vi) •

Sam

ple

rece

ipt –

Doe

s the

ope

ratio

n’s p

olic

y co

ntai

n in

form

atio

n on

oth

er re

quire

men

ts, s

uch

as th

e us

e of

pre

serv

ativ

es, i

nert

gas,

or o

ther

mea

sure

s to

prot

ect s

ampl

e in

tegr

ity?

☐

☐

☐

E5.

1(b)

(2)(

vii)

• Sam

ple

rece

ipt –

Doe

s the

ope

ratio

n’s p

olic

y co

ntai

n th

e ac

cept

ed u

se o

f sam

ple

chai

n of

cus

tody

form

s?

☐

☐

☐

E5.

1(c)

(1) •

Sam

ple

rece

ipt –

Doe

s the

labo

rato

ry h

ave

docu

men

tatio

n or

a

reco

rd o

f eac

h te

st sa

mpl

e?

☐

☐

☐

E5.

1(c)

(1)(

i) • S

ampl

e re

ceip

t – D

oes t

he re

cord

incl

ude

the

nam

e an

d co

ntac

t of

com

plia

nt b

usin

ess o

r ind

ivid

ual t

hat w

as th

e so

urce

of t

he m

ater

ial?

☐

☐

☐

E5.

1(c)

(1)(

ii) •

Sam

ple

rece

ipt –

Doe

s the

reco

rd in

clud

e an

app

ropr

iate

ly

com

plet

e an

d sp

ecifi

c de

scrip

tion

of th

e sa

mpl

e?

☐

☐

☐

E5.

1(c)

(1)(

iii) •

Sam

ple

rece

ipt –

Doe

s the

reco

rd in

clud

e th

e da

te o

f rec

eipt

of

the

sam

ple?

☐

☐

☐

E5.

1(c)

(1)(

iv) •

Sam

ple

rece

ipt –

Doe

s the

reco

rd in

clud

e a

stat

emen

t of t

he

quan

tity

(wei

ght,

volu

me,

num

ber,

or o

ther

am

ount

) of t

he sa

mpl

e?

☐

☐

☐

E5.

1(c)

(1)(

v) •

Sam

ple

rece

ipt –

Doe

s the

reco

rd in

clud

e a

uniq

ue sa

mpl

e id

entif

ier f

or th

e sa

mpl

e?

☐

☐

☐

E5.

1(c)

(2) •

Sam

ple

rece

ipt –

Doe

s the

ope

ratio

n in

form

bus

ines

ses a

nd

com

plia

nt in

divi

dual

s tha

t sub

mit

test

sam

ples

of t

he p

olic

ies e

stab

lishe

d in

se

ctio

n E5

.1(b

)?

☐

☐

☐

SAMPLE

IT

EM

S N

EED

ED

FO

R C

OM

PLI

AN

CE

E5.

2(a)

• Sa

mpl

e H

andl

ing

– D

oes t

he o

pera

tion

have

pro

cedu

res

docu

men

ting

the

track

ing

of th

e sa

mpl

es th

roug

h th

e en

tire

anal

ytic

al p

roce

ss

(by

wei

ght,

volu

me,

num

ber,

or o

ther

app

ropr

iate

mea

sure

) to

prev

ent

dive

rsio

n?

☐

☐

☐

E5.

2(b)

• Sa

mpl

e H

andl

ing

– D

oes t

he o

pera

tion

store

eac

h sa

mpl

e un

der t

he

appr

opria

te c

ondi

tions

to p

rote

ct th

e ph

ysic

al a

nd c

hem

ical

inte

grity

of t

he

sam

ple?

☐

☐

☐

E5.

2(c)

• Sa

mpl

e H

andl

ing

– D

oes t

he o

pera

tion

appr

opria

tely

segr

egat

e,

cont

rol,

or h

old

sam

ples

con

sist

ing

of c

anna

bis o

r can

nabi

s-de

rived

pro

duct

s in

con

trolle

d ar

eas p

endi

ng d

estru

ctio

n or

dis

posa

l?

☐

☐

☐

E5.

2(d)

(1-3

) • S

ampl

e H

andl

ing

– D

oes t

he o

pera

tion

have

a d

ocum

ente

d pr

oced

ure

for c

anna

bis o

r can

nabi

s-de

rived

pro

duct

test

sam

ples

that

are

not

de

stro

yed

durin

g th

e an

alys

is, s

uch

as th

e fo

llow

ing?

Ret

urni

ng th

e sa

mpl

e to

the

indi

vidu

al o

r com

plai

nt b

usin

ess;

Stor

ing

and

reta

inin

g th

e sa

mpl

e in

con

form

ity w

ith o

pera

tion’

s sa

mpl

e re

tent

ion

polic

y; o

r

Des

troyi

ng in

a m

anne

r whi

ch p

reve

nts u

naut

horiz

ed u

se a

nd is

do

cum

ente

d ac

cord

ing

to S

ectio

n 5.

2 (d

)(3).

☐

☐

☐

E5.

2(e)

(1-3

) • S

ampl

e H

andl

ing

–Doe

s the

ope

ratio

n di

spos

e of

any

por

tion

of h

emp

or h

emp-

deriv

ed p

rodu

ct th

at is

not

des

troye

d du

ring

anal

ysis

, by

a m

etho

d su

ch a

s the

follo

win

g?

R

etur

ning

the

sam

ple

to th

e sa

me

com

plai

nt in

divi

dual

or b

usin

ess

that

pro

vide

s a sa

mpl

e, o

r

Stor

age

and

rete

ntio

n of

the

sam

ple

in c

onfo

rmity

with

the

labo

rato

ry o

pera

tions

sam

ple

rete

ntio

n po

licy,

if a

ny; o

r

Dis

pose

d of

in a

ny a

ppro

pria

te m

anne

r?

☐

☐

☐

F6.1

(a) •

Equ

ipm

ent –

Doe

s the

ope

ratio

n d

ocum

ent i

nspe

ctio

n, c

lean

ing,

m

aint

enan

ce, a

nd c

alib

ratio

n of

equ

ipm

ent,

on a

n ap

prop

riate

sche

dule

, as

appl

icab

le?

☐

☐

☐

F6.1

(b) •

Equ

ipm

ent –

Doe

s the

ope

ratio

n do

cum

ent p

roce

dure

s use

d in

the

rout

ine

insp

ectio

n, c

lean

ing,

mai

nten

ance

, tes

ting,

and

cal

ibra

tion

of

equi

pmen

t?

☐

☐

☐

SAMPLE

IT

EM

S N

EED

ED

FO

R C

OM

PLI

AN

CE

F6.1

(b) •

Equ

ipm

ent –

Doe

s the

ope

ratio

n sp

ecify

and

doc

umen

t whe

n re

med

ial a

ctio

n m

ust b

e ta

ken

in th

e ev

ent o

f fai

lure

or m

alfu

nctio

n of

eq

uipm

ent?

The

pro

cedu

res m

ust d

esig

nate

the

pers

onne

l res

pons

ible

for t

he

perfo

rman

ce o

f eac

h op

erat

ion.

☐

☐

☐

F6.1

(c) •

Equ

ipm

ent –

Are

reco

rds m

aint

aine

d of

all

insp

ectio

ns,

mai

nten

ance

, tes

ting,

and

cal

ibra

ting?

☐

☐

☐

F6.1

(c) •

Equ

ipm

ent –

Do

the

reco

rds i

nclu

de th

e da

te o

f the

ope

ratio

n pe

rform

ed, t

he p

roce

dure

use

d, a

nd a

ny d

evia

tions

of a

writ

ten

proc

edur

e?

☐

☐

☐

F6.1

(c) •

Equ

ipm

ent –

Do

the

reco

rds i

nclu

de n

on-r

outin

e re

pairs

on

equi

pmen

t as a

resu

lt of

failu

re a

nd m

alfu

nctio

n?

☐

☐

☐

F6.1

(c) •

Equ

ipm

ent –

Do

the

reco

rds i

nclu

de th

e do

cum

enta

tion

of re

pairs

w

ith th

e na

ture

of r

epai

r, ho

w a

nd w

hen

the

need

for r

epai

r was

disc

over

ed,

and

any

rem

edia

l act

ion

take

n in

resp

onse

to re

pair?

☐

☐

☐

F6.1

(d) •

Equ

ipm

ent –

Doe

s the

ope

ratio

n en

sure

that

com

pute

r sys

tem

s use

d fo

r lab

orat

ory

func

tions

such

as e

lect

roni

c re

cord

s, el

ectro

nic

sign

atur

es, a

nd

hand

writ

ten

sign

atur

es e

xecu

ted

to e

lect

roni

c re

cord

s are

trus

twor

thy,

relia

ble,

an

d ge

nera

lly e

quiv

alen

t to

hand

writ

ten

sign

atur

es e

xecu

ted

on p

aper

?

☐

☐

☐

F6.2

(a)(

1) •

Rea

gent

s – D

oes t

he o

pera

tion

labe

l ana

lytic

reag

ents

, sol

utio

ns,

and

refe

renc

e st

anda

rds w

ith a

ppro

pria

te in

dica

tions

of i

dent

ity, d

ate

rece

ived

or

pre

pare

d, e

xpira

tion

or re

qual

ifica

tion

date

, and

, whe

re a

pplic

able

, co

ncen

tratio

n or

pur

ity, s

tora

ge re

quire

men

ts, a

nd d

ate

open

ed?

☐

☐

☐

F6.2

(a)(

2) •

Rea

gent

s – A

re a

naly

tical

reag

ents

, sol

utio

ns, a

nd re

fere

nce

stan

dard

s sto

red

unde

r app

ropr

iate

con

ditio

ns to

min

imiz

e de

grad

atio

n or

de

terio

ratio

n of

the

mat

eria

l?

☐

☐

☐

F6.2

(a)(

3) •

Rea

gent

s – A

re a

naly

tical

reag

ents

, sol

utio

ns, r

efer

ence

stan

dard

s w

ithin

thei

r exp

iratio

n re

qual

ifica

tion

date

s at t

he ti

me

of u

se?

☐

☐

☐

F6.2

(b) •

Rea

gent

s – D

oes t

he o

pera

tion

prop

erly

dis

card

det

erio

rate

d or

ou

tdat

ed re

agen

ts a

nd so

lutio

ns?

☐

☐

☐

F6.2

(c) •

Rea

gent

s – D

oes a

labo

rato

ry o

pera

tion

acqu

ire c

omm

erci

al

refe

renc

e st

anda

rds f

or th

e ca

nnab

inoi

ds b

eing

ana

lyze

d?

☐

☐

☐

F6.2

(d) •

Rea

gent

s – If

the

oper

atio

n in

tern

ally

pro

duce

s sta

ndar

ds, a

re

stan

dard

ana

lytic

al te

chni

ques

use

d to

doc

umen

t the

pur

ity a

nd c

once

ntra

tion

of th

e in

tern

ally

pro

duce

d st

anda

rd?

☐

☐

☐

SAMPLE

IT

EM

S N

EED

ED

FO

R C

OM

PLI

AN

CE

F6.2

(e) •

Rea

gent

s – If

the

oper

atio

n in

tern

ally

pro

duce

s sta

ndar

ds, d

oes t

he

oper

atio

n cr

eate

a c

ertif

icat

e of

ana

lysi

s (C

OA

) for

eac

h lo

t of r

efer

ence

st

anda

rds?

*

☐

☐

☐

F6.2

(e) •

Rea

gent

s – If

the

oper

atio

n in

tern

ally

pro

duce

s sta

ndar

ds, i

s eac

h C

OA

kep

t on

file

and

lot n

umbe

r of t

he re

fere

nce

stan

dard

use

d an

d re

cord

ed

in th

e do

cum

enta

tion

for e

ach

anal

ysis

, whe

re a

pplic

able

?

☐

☐

☐

G7.

1(a)

(1) •

Ana

lytic

al P

roce

dure

s – D

oes t

he o

pera

tion

utili

ze a

naly

tical

m

etho

ds th

at a

re fi

t for

pur

pose

in th

eir t

estin

g of

eac

h ca

nnab

is p

rodu

ct?

☐

☐

☐

G7.

1(a)

(2) •

Ana

lytic

al P

roce

dure

s – D

oes t

he o

pera

tion

have

doc

umen

tatio

n de

mon

stra

ting

the

prof

icie

ncy

of e

ach

anal

yst?

☐

☐

☐

G7.

1(a)

(3) •

Ana

lytic

al P

roce

dure

s – D

oes t

he o

pera

tion

have

writ

ten

proc

edur

es fo

r the

follo

win

g, w

here

app

licab

le:

Sa

mpl

e pr

epar

atio

n

R

eage

nt so

lutio

n, a

nd re

fere

nce

stan

dard

pre

para

tion

Inst

rum

ent s

et u

p

St

anda

rdiz

atio

n of

vol

umet

ric re

agen

t sol

utio

ns

D

ata

acqu

isiti

on

C

alcu

latio

n of

resu

lts

☐

☐

☐

G7.

1(a)

(4) •

Ana

lytic

al P

roce

dure

s – H

as th

e op

erat

ion,

as a

pplic

able

to e

ach

anal

ytic

al m

etho

d us

ed, s

peci

fied

the

requ

irem

ents

for a

ccur

acy,

pre

cisi

on,

linea

rity,

spec

ifici

ty, l

imit

of d

etec

tion,

lim

it of

qua

ntita

tion,

and

oth

er d

ata

qual

ity p

aram

eter

s?

☐

☐

☐

G7.

1(a)

(5) •

Ana

lytic

al P

roce

dure

s – D

oes t

he o

pera

tion

docu

men

t any

de

viat

ions

from

app

rove

d pr

otoc

ols o

r sta

ndar

d op

erat

ing

proc

edur

es?

☐

☐

☐

G7.

1(b)

• A

naly

tical

Pro

cedu

res

– D

oes t

he la

bora

tory

use

onl

y pr

imar

y or

se

cond

ary

stan

dard

s for

qua

ntita

tive

anal

yses

? ☐

☐

☐

G7.

2(a)

• R

ecor

ding

of a

naly

tical

dat

a (n

on-a

utom

ated

syst

ems)

– A

re d

ata

from

test

sam

ples

reco

rded

dire

ctly

, pro

mpt

ly a

nd le

gibl

y?

☐

☐

☐

G7.

2(a)

• R

ecor

ding

of a

naly

tical

dat

a (n

on-a

utom

ated

syst

ems)

– I

s the

da

ta a

nnot

ated

with

the

date

of e

ntry

and

sign

ed o

r ini

tiale

d by

the

pers

on

reco

rdin

g th

e da

ta?

☐

☐

☐

SAMPLE

IT

EM

S N

EED

ED

FO

R C

OM

PLI

AN

CE

G7.

2(a)

• R

ecor

ding

of a

naly

tical

dat

a (n

on-a

utom

ated

syst

ems)

– D

o an

y ch

ange

s in

entri

es n

ot o

bscu

re o

rigin

al e

ntrie

s and

indi

cate

the

reas

on fo

r suc

h ch

ange

, with

dat

e an

d si

gnat

ure

or in

itial

at t

he ti

me

of c

hang

e?

☐

☐

☐

G7.

2(b)

• R

ecor

ding

of a

naly

tical

dat

a (a

utom

ated

syst

ems)

– Is

the

oper

ator

or t

echn

icia

n re

spon

sible

for i

nput

ting

data

into

aut

omat

ed d

ata

colle

ctio

n sy

stem

s ide

ntifi

ed w

ith th

e da

te o

f dat

a in

put?

☐

☐

☐

G7.

3(1)

• D

ata

revi

ew –

In th

e re

porti

ng o

f the

fina

l res

ult,

is th

ere

verif

icat

ion

that

cal

cula

tions

or o

ther

dat

a pr

oces

sing

step

s wer

e pe

rform

ed

corr

ectly

?

☐

☐

☐

G7.

3(2)

• D

ata

revi

ew –

In

the

repo

rting

of t

he fi

nal r

esul

t, do

es th

e da

ta

mee

t any

spec

ified

dat

a qu

ality

requ

irem

ents

, suc

h as

for a

ccur

acy,

pre

cisi

on,

and

linea

rity,

etc

.?

☐

☐

☐

G7.

3(3)

• D

ata

revi

ew –

In

the

repo

rting

of t

he fi

nal r

esul

t, w

ere

refe

renc

e st

anda

rds u

sed

of a

ppro

pria

te p

urity

and

with

in e

xpira

tion

or re

qual

ifica

tion

date

s?

☐

☐

☐

G7.

3(4)

• D

ata

revi

ew –

In

the

repo

rting

of t

he fi

nal r

esul

t, w

ere

volu

met

ric

solu

tions

pro

perly

stan

dard

ized

bef

ore

use?

☐

☐

☐

G7.

3(5)

• D

ata

revi

ew –

In

the

repo

rting

of t

he fi

nal r

esul

t, ha

s any

test

or

mea

surin

g eq

uipm

ent u

sed

been

pro

perly

test

ed, v

erifi

ed, a

nd/o

r cal

ibra

ted

and

is w

ithin

its v

erifi

catio

n or

cal

ibra

tion

perio

d?

☐

☐

☐

G7.

4(a)

• D

ata

stor

age

– D

oes t

he o

pera

tion

reta

in a

ll ra

w d

ata,

do

cum

enta

tion,

pro

toco

ls, a

nd fi

nal r

epor

ts a

ssoc

iate

d w

ith a

naly

sis o

f tes

t sa

mpl

es fo

r a p

erio

d of

2 y

ears

from

the

date

of c

ompl

etio

n of

the

anal

ysis

?s

☐

☐

☐

G7.

4(b)

(1) •

Dat

a st

orag

e –

Are

labo

rato

ry re

cord

s ind

icat

ed in

G7.

4(a)

, w

heth

er st

ored

on

the

prem

ises

or r

emot

ely,

mai

ntai

ned

in a

man

ner t

hat

allo

ws r

etrie

val a

s nee

ded?

☐

☐

☐

G7.

4(b)

(2) •

Dat

a st

orag

e –

Are

labo

rato

ry re

cord

s ind

icat

ed in

G7.

4(a)

, w

heth

er st

ored

on

the

prem

ises

or r

emot

ely,

mai

ntai

ned

in c

ondi

tions

of

stor

age

that

min

imiz

e de

terio

ratio

n th

roug

hout

the

rete

ntio

n pe

riod?

☐

☐

☐

G7.

4(b)

(3) •

Dat

a st

orag

e –

Are

labo

rato

ry re

cord

s ind

icat

ed in

G7.

4(a)

, w

heth

er st

ored

on

the

prem

ises

or r

emot

ely,

mai

ntai

ned

in a

man

ner t

hat

prev

ents

una

utho

rized

alte

ratio

n?

☐

☐

☐

SAMPLE

IT

EM

S N

EED

ED

FO

R C

OM

PLI

AN

CE

G7.

4(c)

• D

ata

stor

age

– D

oes t

he o

pera

tion

desi

gnat

e an

indi

vidu

al

resp

onsib

le fo

r rec

ords

mai

nten

ance

?

☐

☐

☐

G7.

4(d)

• D

ata

stor

age

– D

oes t

he o

pera

tion

ensu

re th

at o

nly

auth

oriz

ed

pers

onne

l may

ent

er o

r acc

ess t

he m

aint

aine

d re

cord

s?

☐

☐

☐

G7.

5(a)

• D

ata

repo

rtin

g -

Are

the

anal

ytic

al re

sults

of a

ny te

st sa

mpl

e th

e pr

oper

ty o

f the

com

plia

nt b

usin

ess o

r com

plia

nt in

divi

dual

whi

ch p

rovi

ded

the

sam

ple

(unl

ess c

ontra

cts o

r oth

er w

ritte

n ag

reem

ents

spec

ify o

ther

wis

e)?*

☐

☐

☐

G7.

5(b)

(1) •

Dat

a re

port

ing

- D

oes t

he o

pera

tion’

s lab

orat

ory

repo

rt gi

ven

to

a cl

ient

con

tain

the

date

of r

ecei

pt o

f the

test

sam

ple?

☐

☐

☐

G7.

5(b)

(2) •

Dat

a re

port

ing

- D

oes t

he o

pera

tion’

s lab

orat

ory

repo

rt gi

ven

to

a cl

ient

con

tain

a d

escr

iptio

n of

the

type

or f

orm

of t

he te

st sa

mpl

e (le

af,

flow

er, p

owde

r, oi

l, sp

ecifi

c ed

ible

pro

duct

, etc

.)?

☐

☐

☐

G7.

5(b)

(3) •

Dat

a re

port

ing

- D

oes t

he o

pera

tion’

s lab

orat

ory

repo

rt gi

ven

to

a cl

ient

con

tain

the

uniq

ue sa

mpl

e id

entif

ier a

s est

ablis

hed

in a

ccor

danc

e w

ith

subp

arag

raph

5.1

(b)(1

)(v)

?

☐

☐

☐

G7.

5(b)

(4) •

Dat

a re

port

ing

- D

oes t

he o

pera

tion’

s lab

orat

ory

repo

rt gi

ven

to

a cl

ient

con

tain

info

rmat

ion

on w

heth

er sa

mpl

ing

was

per

form

ed b

y th

e la

bora

tory

ope

ratio

n, b

y th

e co

mpl

iant

bus

ines

s or i

ndiv

idua

l whi

ch su

bmitt

ed

the

test

sam

ple,

or b

y a

third

-par

ty?

☐

☐

☐

G7.

5(b)

(5) •

Dat

a re

port

ing

- D

oes t

he o

pera

tion’

s lab

orat

ory

repo

rt gi

ven

to

a cl

ient

con

tain

the

date

on

whi

ch a

naly

sis o

ccur

red?

☐

☐

☐

G7.

5(b)

(6) •

Dat

a re

port

ing

- D

oes t

he o

pera

tion’

s lab

orat

ory

repo

rt gi

ven

to

a cl

ient

con

tain

the

anal

ytic

al m

etho

d us

ed, i

nclu

ding

at a

min

imum

id

entif

icat

ion

of th

e ty

pe o

f ana

lytic

al e

quip

men

t use

d (e

.g.,

GC

, HPL

C, U

V,

etc.

)?

☐

☐

☐

G7.

5(b)

(7) •

Dat

a re

port

ing

- D

oes t

he o

pera

tion’

s lab

orat

ory

repo

rt gi

ven

to

a cl

ient

con

tain

the

anal

ytic

al re

sults

, inc

ludi

ng u

nits

of m

easu

re w

here

ap

plic

able

?

☐

☐

☐

G7.

5(b)

(8) •

Dat

a re

port

ing

- D

oes t

he o

pera

tion’

s lab

orat

ory

repo

rt gi

ven

to

a cl

ient

con

tain

the

iden

tity

of th

e su

perv

isor

y or

man

agem

ent p

erso

nnel

who

re

view

ed a

nd v

erifi

ed th

e da

ta a

nd re

sults

and

ens

ured

that

dat

a qu

ality

, ca

libra

tion,

and

oth

er a

pplic

able

requ

irem

ents

wer

e m

et?

☐

☐

☐

SAMPLE

IT

EM

S N

EED

ED

FO

R C

OM

PLI

AN

CE

G7.

5(b)

(9) •

Dat

a re

port

ing

- D

oes t

he o

pera

tion’

s lab

orat

ory

repo

rt gi

ven

to

a cl

ient

con

tain

the

nam

e, a

ddre

ss, a

nd c

onta

ct in

form

atio

n of

the

labo

rato

ry

oper

atio

n?

☐

☐

☐

G7.

5(c)

(1) •

Dat

a re

port

ing

- If a

labo

rato

ry o

pera

tion

repo

rts c

anna

bino

id

valu

es o

ther

than

thos

e di

rect

ly m

easu

red

in th

e te

st sa

mpl

e, d

oes t

he re

port

cont

ain

all c

alcu

latio

ns o

r con

vers

ion

fact

ors u

sed

to d

eter

min

e th

e re

porte

d no

n-m

easu

red

resu

lts?

☐

☐

☐

G7.

5(c)

(2) •

Dat

a re

port

ing

- If a

labo

rato

ry o

pera

tion

repo

rts c

anna

bino

id

valu

es o

ther

than

thos

e di

rect

ly m

easu

red

in th

e te

st sa

mpl

e, d

oes t

he re

port

cont

ain

a w

ritte

n ex

plan

atio

n of

ass

umpt

ions

, if a

ny, a

ssoc

iate

d w

ith th

e re

porte

d no

n-m

easu

red

resu

lts, s

uch

as th

e ro

ute

of c

onsu

mpt

ion

of th

e pr

oduc

t rep

rese

nted

by

the

test

sam

ple?

☐

☐

☐

G7.

5(d)

• D

ata

repo

rtin

g –

Doe

s the

labo

rato

ry re

port

stat

e th

at re

porte

d an

alyt

ical

resu

lts a

pply

onl

y to

the

test

sam

ple

rece

ived

? ☐

☐

☐

*N

ot

req

uire

d b

y A

HP

A d

oc

um

en

t, n

ot

ne

ce

ssa

rily

an

au

dit p

oin

t. SAMPLE

A1.

1 • S

ubje

ct o

pera

tions

– Is

this

ope

ratio

n is

subj

ect t

o st

ate

and/

or lo

cal

over

sigh

t?

☐

☐

☐

A1.

2 • O

ther

stat

utor

y pr

ovis

ions

and

reg

ulat

ions

– Is

this

ope

ratio

n co

mpl

iant

(i.e

. has

a li

cens

e in

goo

d st

andi

ng, c

ertif

icat

e of

occ

upan

cy,

conf

iden

tialit

y re

quire

men

ts, l

abel

ing

and

test

ing

requ

irem

ents

, etc

.) w

ith a

ll ap

plic

able

regu

latio

ns in

the

juris

dict

ion

it op

erat

es?

☐

☐

☐

B2.

1(a)

• T

ypes

of d

istr

ibut

ion

oper

atio

ns –

Is th

is o

pera

tion

a st

oref

ront

, a

stor

efro

nt w

ith a

del

iver

y se

rvic

e, d

eliv

ery

serv

ice,

or d

irect

from

gar

den

oper

atio

n? O

r is t

his o

pera

tion

a gr

owin

g co

oper

ativ

e su

bjec

t to

regu

lato

ry

over

sigh

t?

☐

☐

☐

B2.

1(b)

(1) •

Can

nabi

s acq

uisi

tion

and

dist

ribu

tion

– D

oes t

he o

pera

tion

have

pol

icie

s and

pro

cedu

res t

o lim

it th

e di

strib

utio

n of

can

nabi

s to

cann

abis

th

at h

as b

een:

Cul

tivat

ed b

y th

e op

erat

ion

itsel

f;

Cul

tivat

ed b

y a

co-o

wne

d op

erat

ion;

or

O

btai

ned

from

a c

ultiv

atio

n op

erat

ion

or v

endo

r?

☐

☐

☐

SAMPLE

B2.

1(b)

(2) •

Can

nabi

s-de

rive

d pr

oduc

t dis

trib

utio

n –

Doe

s the

ope

ratio

n ha

ve p

olic

ies a

nd p

roce

dure

s to

limit

the

dist

ribut

ion

of c

anna

bis-

deriv

ed

prod

ucts

to c

anna

bis-

deriv

ed p

rodu

cts t

hat h

ave

been

:

Man

ufac

ture

d by

the

oper

atio

n its

elf;

M

anuf

actu

red

by a

co-

owne

d op

erat

ion;

or

O

btai

ned

from

a m

anuf

actu

ring

oper

atio

n or

ven

dor?

☐

☐

☐

B2.

2 • A

ncill

ary

oper

atio

ns –

If th

ere

are

oper

atio

ns o

ther

than

can

nabi

s di

strib

utio

n co

nduc

ted

at th

e lo

catio

n, is

ther

e su

ffici

ent e

vide

nce

that

thes

e an

cilla

ry o

pera

tions

are

con

duct

ed in

com

plia

nce

with

all

regu

latio

ns in

the

juris

dict

ion

it op

erat

es?

☐

☐

☐

B2.

3(a,

b, c

) • P

erso

nnel

trai

ning

– D

oes t

he o

pera

tion

have

a m

echa

nism

for

com

mun

icat

ing

with

all

empl

oyee

s and

hav

e ev

iden

ce th

at e

mpl

oyee

s hav

e re

ceiv

ed tr

aini

ng, i

nclu

ding

the

follo

win

g?

Sp

ecifi

c us

es o

f can

nabi

s or a

spec

ific

cann

abis

-der

ived

pro

duct

;

Clin

ical

app

licat

ion

of th

e sp

ecifi

c co

nstit

uent

s;

Th

e la

ws,

regu

latio

ns, a

nd p

olic

ies r

elev

ant t

o pr

ovid

ing

cann

abis

pr

oduc

ts in

its j

uris

dict

ion

as w

ell a

s U.S

. fed

eral

law

s and

re

gula

tions

; and

Inst

ruct

ion

for r

egul

ator

y in

spec

tion

prep

ared

ness

and

law

-en

forc

emen

t int

erac

tions

.

☐

☐

☐

B2.

3(d,

e) •

CPR

– If

the

oper

atio

n is

a st

oref

ront

ope

ratio

n, h

as it

ens

ured

th

at a

pro

perly

trai

ned

empl

oyee

is p

repa

red

to a

dmin

iste

r CPR

at a

ll tim

es

whe

n th

e op

erat

ion

is o

pen

for b

usin

ess?

NO

TE: t

here

may

be

valid

lega

l re

ason

s to

proh

ibit

com

plia

nce

with

this

regu

latio

n in

cer

tain

juris

dict

ions

.

☐

☐

☐

B2.

4(a)

(1) •

Phy

sica

l fac

ilitie

s – D

oes t

he o

pera

tion

have

suffi

cien

t evi

denc

e th

at it

ope

rate

s in

adhe

renc

e w

ith a

ll re

gula

tions

in th

e ju

risdi

ctio

n it

oper

ates

, in

clud

ing:

Loca

tions

and

zon

ing,

for a

ll ty

pe o

f ope

ratio

ns a

t the

faci

lity;

Bus

ines

s hou

rs;

Pa

rkin

g;

D

rive-

thro

ugh

serv

ices

; and

Sign

age?

☐

☐

☐

SAMPLE

B2.

4(a)

(2) •

Phy

sica

l fac

ilitie

s – D

oes t

he o

pera

tion

have

SO

Ps a

nd re

cord

ke

epin

g in

pla

ce su

ffici

ent t

o pr

ovid

e ev

iden

ce th

at it

is m

aint

aine

d in

a c

lean

an

d or

derly

fash

ion?

☐

☐

☐

B2.

4(a)

(3) •

Phy

sica

l fac

ilitie

s – Is

this

ope

ratio

n eq

uipp

ed w

ith u

tens

ils a

nd

equi

pmen

t as a

re n

eces

sary

to c

ondu

ct o

pera

tions

, inc

ludi

ng a

ncill

ary

oper

atio

ns a

s des

crib

ed in

sect

ion

2.2,

that

occ

ur a

t the

faci

lity?

☐

☐

☐

B2.

4(a)

(4) •

Pri

vacy

of t

rans

actio

ns –

Doe

s the

ope

ratio

n ha

ve e

vide

nce

it ha

s im

plem

ente

d a

priv

acy

of fi

nanc

ial t

rans

actio

ns p

olic

y?

☐

☐

☐

B2.

4(a)

(5) •

Pat

ient

lega

l inf

orm

atio

n –

Doe

s the

ope

ratio

n ha

ve in

form

atio

n av

aila

ble

to p

atie

nts a

nd c

areg

iver

s reg

ardi

ng lo

cal,

stat

e an

d fe

dera

l law

s on

cann

abis

pos

sess

ion?

☐

☐

☐

B2.

4(b)

• St

orag

e of

pro

duct

and

cas

h –

Doe

s the

ope

ratio

n do

the

follo

win

g?

A

dequ

atel

y re

frige

rate

pro

duct

s tha

t req

uire

refri

gera

tion;

Prov

ide

and

use

a se

cure

are

a fo

r sto

rage

of a

ll ca

nnab

is p

rodu

cts;

an

d

Prov

ide

and

use

a se

cure

are

a to

stor

e m

oney

and

hav

e pr

oced

ures

in

plac

e to

rem

ove

mon

ey fr

om th

e pr

emis

es fr

eque

ntly

?

☐

☐

☐

B2.

4(c)

(1) •

AD

A –

Doe

s the

ope

ratio

n ha

ve su

ffici

ent e

vide

nce

that

it is

in

com

plia

nce

with

app

licab

le A

mer

ican

s with

Dis

abili

ties A

ct p

rovi

sion

s or

equi

vale

nt re

gula

tions

in th

e ju

risdi

ctio

n it

oper

ates

?

☐

☐

☐

B2.

4(c)

(2) •

On-

site

con

sum

ptio

n –

Doe

s the

ope

ratio

n ha

ve a

pol

icy

in p

lace

re

gard

ing

on-s

ite c

onsu

mpt

ion?

If th

e op

erat

ion

allo

ws o

n-si

te c

onsu

mpt

ion,

is

it in

com

plia

nce

with

all

regu

latio

ns in

the

juris

dict

ion

whi

ch it

ope

rate

s?

Doe

s the

con

sum

ptio

n po

licy

addr

ess t

he fo

llow

ing?

The

type

or t

ypes

of c

onsu

mpt

ion

allo

wed

;

A ti

me

limit

to o

n-sit

e co

nsum

ptio

n if

advi

sabl

e;

A

ven

tilat

ion

plan

if n

eede

d;

A

pro

toco

l to

prev

ent a

nd a

ddre

ss o

ver-

med

icat

ion;

and

Any

add

ition

al is

sues

as n

eede

d.

☐

☐

☐

SAMPLE

B2.

5(a)

,(b)(

1)(i)

• Se

curi

ty p

ract

ices

– D

oes t

he o

pera

tion

have

sign

ifica

nt

evid

ence

that

it is

in c

ompl

ianc

e w

ith re

quire

d se

curit

y re

gula

tions

in th

e ju

risdi

ctio

n it

oper

ates

, inc

ludi

ng su

ffici

ent i

n-st

ore

secu

rity

pers

onne

l to

ensu

re st

aff a

nd p

atie

nt se

curit

y; in

-sto

re se

curit

y ca

mer

as; a

nd e

ither

secu

rity

pers

onne

l or

vid

eo m

onito

ring

of d

edic

ated

par

king

are

a?

☐

☐

☐

B2.

5(b)

(1)(

ii)(A

)&(B

) • S

ecur

ity p

ract

ices

– If

this

ope

ratio

n is

a d

eliv

ery

serv

ice,

doe

s the

ope

ratio

n ha

ve si

gnifi

cant

evi

denc

e th

at it

is in

com

plia

nce

with

requ

ired

secu

rity

regu

latio

ns in

the

juris

dict

ion

it op

erat

es, i

nclu

ding

su

ffici

ent s

ecur

ity p

erso

nnel

at t

he fa

cilit

y w

here

pro

duct

s are

acq

uire

d,

stor

ed, a

nd/o

r pro

cess

ed to

ens

ure

the

safe

ty o

f sta

ff an

d th

e se

curit

y of

all

prod

ucts

? D

oes i

t pro

vide

app

ropr

iate

trai

ning

for d

eliv

ery

staf

f to

ensu

re

awar

enes

s on

how

to m

aint

ain

pers

onal

and

pro

duct

safe

ty, i

nclu

ding

con

tact

in

form

atio

n fo

r pol

ice

and

othe

r em

erge

ncy

pers

onne

l?

☐

☐

☐

B2.

5(b)

(1)(

ii)(C

)&(D

) • S

ecur

ity p

ract

ices

– D

oes t

he d

eliv

er o

pera

tion

have

si

gnifi

cant

evi

denc

e th

at it

del

iver

s ON

LY to

priv

ate

addr

esse

s and

nev

er to

a

publ

ic lo

catio

n, a

nd th

at it

is in

com

plia

nce

with

all

loca

l reg

ulat

ions

rega

rdin

g pe

rmis

sibl

e de

liver

y ar

eas a

nd h

ours

of o

pera

tion?

☐

☐

☐

B2.

5(b)

(1)(

iii)(

A) •

Sec

urity

pra

ctic

es –

If th

is o

pera

tion

is a

dire

ct-fr

om-

gard

en o

r a g

row

ing

co-o

p, d

oes i

t hav

e si

gnifi

cant

evi

denc

e th

at it

has

the

nece

ssar

y se

curit

y pr

actic

es in

pla

ce a

t the

gro

win

g fa

cilit

y an

d at

any

as

soci

ated

loca

tions

whe

re c

anna

bis o

r can

nabi

s-de

rived

pro

duct

s or m

oney

ar

e ke

pt to

ens

ure

the

safe

ty o

f sta

ff an

d th

e se

curit

y of

can

nabi

s on

site

?

☐

☐

☐

B2.

5(b)

(2) •

Arm

ed se

curi

ty –

Doe

s the

ope

ratio

n re

frain

from

usi

ng a

rmed

se

curit

y pe

rson

nel o

r hav

e su

ffici

ent e

vide

nce

that

they

are

usi

ng a

rmed

se

curit

y in

stric

t acc

orda

nce

with

all

rele

vant

lega

l req

uire

men

ts in

the

juris

dict

ion

they

ope

rate

?

☐

☐

☐

B2.

5(b)

(3) •

Sec

urity

trai

ning

– D

oes t

he o

pera

tion

have

suffi

cien

t evi

denc

e th

at it

pro

vide

s sta

ff w

ith se

curit

y pr

oced

ures

and

ens

ures

staf

f is a

war

e of

th

eir i

ndiv

idua

l rol

es a

nd re

spon

sibili

ties?

☐

☐

☐

B2.

5(c)

• Se

curi

ty a

t anc

illar

y op

erat

ions

– If

the

oper

atio

n is

also

eng

aged

in

cul

tivat

ion,

pro

cess

ing,

or m

anuf

actu

ring

oper

atio

ns, d

oes i

t hav

e su

ffici

ent

evid

ence

that

it is

com

plia

nt w

ith se

curit

y re

quire

men

ts fo

r suc

h op

erat

ions

?

☐

☐

☐

SAMPLE

C3.

1(a)

• C

anna

bis p

rovi

sion

rec

ords

– D

oes t

he o

pera

tion

offe

r the

fo

llow

ing

item

s, as

allo

wed

by

regu

latio

ns in

the

juris

dict

ion

if op

erat

es:

smok

ed c

anna

bis,

vapo

rized

can

nabi

s, or

al c

anna

bis,

and/

or to

pica

l can

nabi

s?

☐

☐

☐

C3.

1(b)

(1),

(2),

(3) •

Can

nabi

s pro

visi

on r

ecor

ds –

Doe

s the

ope

ratio

n m

aint

ain

up-to

-dat

e re

cord

s on

all c

anna

bis p

rodu

cts i

t pro

vide

s (se

e C

3.1(

a))

incl

udin

g th

e fo

llow

ing?

Iden

tific

atio

n of

eac

h ca

nnab

is a

nd c

anna

bis-

deriv

ed p

rodu

ct it

pr

ovid

es is

pro

vide

d by

a c

o-ow

ned

oper

atio

n or

from

an

oper

atio

n th

at is

not

co-

owne

d; o

r

Info

rmat

ion

to in

dica

te id

entif

icat

ion

of th

e cu

ltiva

tor,

proc

esso

r, m

anuf

actu

rer a

nd/o

r ven

dor o

f eac

h ca

nnab

is p

rodu

ct, i

f pro

duce

d by

an

oper

atio

n th

at is

not

co-

owne

d?

☐

☐

☐

C3.

1(b)

(4) •

Can

nabi

s pro

visi

on r

estr

ictio

ns –

If th

e op

erat

ion

is su

bjec

t to

rest

rictio

ns o

n th

e pr

ovis

ion

of c

anna

bis,

such

as l

imita

tion

rega

rdin

g w

hat

empl

oyee

s may

and

may

not

pro

vide

var

ious

can

nabi

s pro

duct

s to

com

plia

nt

indi

vidu

als o

r lim

itatio

ns o

n w

hich

com

plia

nt in

divi

dual

s may

or m

ay n

ot

obta

in sp

ecifi

c pr

oduc

ts, d

oes i

t hav

e su

ffici

ent e

vide

nce

to sh

ow th

at it

is in

co

mpl

ianc

e?

☐

☐

☐

C3.

2(a)

• C

anna

bis p

rodu

ct a

cqui

sitio

n –

If th

e op

erat

ion

rece

ives

can

nabi

s pr

oduc

ts fr

om o

ne o

r mor

e cu

ltiva

tion,

pro

cess

ing,

or m

anuf

actu

ring

oper

atio

n, o

r fro

m o

ne o

r mor

e ve

ndor

s, h

as it

est

ablis

hed

and

impl

emen

ted

polic

ies f

or th

e ac

quis

ition

of c

anna

bis o

r can

nabi

s-de

rived

pro

duct

that

are

co

mpl

iant

with

any

regu

latio

n in

the

juris

dict

ion

it op

erat

es, i

nclu

ding

pol

icie

s on

the

follo

win

g?

Lo

catio

ns fo

r rec

eipt

of c

anna

bis p

rodu

cts;

Sche

dulin

g of

del

iver

ies t

o be

mad

e by

eith

er v

endo

rs w

ith sp

ecifi

c ap

poin

tmen

ts, o

r by

esta

blis

hing

ope

n ve

ndin

g tim

es, d

urin

g w

hich

an

y ve

ndor

may

mak

e a

deliv

ery

with

out a

spec

ific

appo

intm

ent;

and

A

ppro

pria

te p

ract

ices

for v

endo

rs a

nd c

ultiv

atio

n, p

roce

ssin

g, o

r m

anuf

actu

ring

oper

atio

n w

ith re

gard

to c

ultiv

atio

n pr

actic

es,

proc

essi

ng o

r man

ufac

turin

g pr

actic

es, p

acka

ging

and

/or l

abel

ing,

ch

emic

al a

naly

sis,

or a

ppro

pria

te tr

ansp

orta

tion

cond

ition

s (su

ch a

s re

frige

ratio

n).

☐

☐

☐

SAMPLE

C3.

2(b)

(1) •

Can

nabi

s pro

duct

rec

ords

– D

oes t

he o

pera

tion

mai

ntai

n ad

equa

te re

cord

s of e

ach

rece

ipt o

f can

nabi

s pro

duct

, inc

ludi

ng th

e fo

llow

ing?

The

nam

e (o

r ide

ntifi

catio

n) o

f the

cul

tivat

ion,

pro

cess

ing,

or

man

ufac

turin

g op

erat

ion

or v

endo

r pro

vidi

ng th

e ca

nnab

is p

rodu

ct;

A

des

crip

tion

of th

e ca

nnab

is p

rodu

ct o

f suf

ficie

nt sp

ecifi

city

; and

A st

atem

ent o

f the

qua

ntity

of e

ach

cann

abis

pro

duct

?

☐

☐

☐

C3.

2(b)

(2),

(3) •

Can

nabi

s pro

duct

rec

ords

– If

the

oper

atio

n is

a st

oref

ront

, do

es it

hav

e po

licie

s and

pro

cedu

res i

n pl

ace

that

min

imiz

e th

e de

liver

y of

pr

oduc

ts a

t tim

es a

nd in

loca

tions

whe

re c

ompl

iant

indi

vidu

als a

re p

rese

nt

(spa

ce a

llow

ing)

? D

oes i

t inf

orm

all

oper

atio

ns a

nd v

endo

rs o

f suc

h po

licie

s?

☐

☐

☐

C3.

3(a)

• C

anna

bis i

nfor

mat

ion

– D

oes t

he o

pera

tion

have

suffi

cien

t ev

iden

ce th

at a

ny in

form

atio

n it

prov

ides

, whe

ther

writ

ten

or v

erba

l, ab

out t

he

iden

tity,

qua

lity,

and

cul

tivat

ion

cond

ition

s of c

anna

bis i

s acc

urat

e?

☐

☐

☐

C3.

3(b)

(1),

(2),

& (3

) • C

anna

bis p

rodu

ct te

stin

g –

If th

e op

erat

ion

cond

ucts

te

stin

g on

can

nabi

s pro

duct

s doe

s it p

rope

rly d

iscl

ose

the

exte

nt a

nd ty

pe o

f te

stin

g it

cond

ucts

, or c

ause

s to

have

con

duct

ed, o

n th

e ca

nnab

is it

pro

vide

s, in

clud

ing

the

follo

win

g?

Th

e ty

pe o

f tes

t or e

xam

inat

ion

used

, if a

ny, t

o de

term

ine

the

parti

cula

r stra

in o

r cul

tivar

of e

ach

lot o

f can

nabi

s pro

vide

d;

W

heth

er o

r not

the

cann

abis

pro

vide

d is

test

ed to

det

erm

ine

the

quan

titat

ive

leve

ls o

f con

stitu

ents

and,

if so

, the

type

of t

estin

g us

ed;

and

W

heth

er o

r not

the

cann

abis

pro

vide

d is

test

ed to

det

erm

ine

the

abse

nce

or p

rese

nce

of sp

ecifi

c cl

asse

s of p

oten

tial c

onta

min

ants

an

d, if

so, t

he ty

pe o

f tes

ting

used

for a

ny o

f the

follo

win

g:

pest

icid

es, y

east

s and

mol

ds, o

r oth

er m

icro

biol

ogic

al c

onta

min

ants

.

☐

☐

☐

SAMPLE

C3.

3(b)

(4) •

Can

nabi

s pro

duct

test

ing

– If

the

oper

atio

n co

nduc

ts te

stin

g on

th

e pr

oduc

ts it

pro

vide

s, do

es it

hav

e si

gnifi

cant

evi

denc

e th

at th

e in

form

atio

n re

quire

d to

be

disc

lose

d is

mad

e av

aila

ble

at e

ach

phys

ical

faci

lity

mai

ntai

ned

by a

stor

efro

nt d

istri

butio

n op

erat

ion

via

one

or m

ore

of th

e fo

llow

ing

met

hods

? Po

stin

g re

adily

vis

ible

sign

age;

Prov

idin

g pr

inte

d ha

ndou

ts;

Po

stin

g on

any

web

site

at w

hich

pro

duct

s are

ava

ilabl

e fo

r ord

erin

g an

d pu

rcha

se; o

r

Post

ing

the

info

rmat

ion

so th

at c

ompl

iant

indi

vidu

als w

ill se

e th

e in

form

atio

n pr

ior t

o or

derin

g or

pur

chas

ing

prod

ucts

?

☐

☐

☐

C3.

3(c)

• C

anna

bis-

deri

ved

prod

uct i

nfor

mat

ion

– Is

the

info

rmat

ion

prov

ided

by

the

oper

atio

n ab

out t

he c

anna

bis-

deriv

ed p

rodu

cts i

t pro

vide

s av

aila

ble

in a

man

ner t

hat i

s com

plia

nt w

ith in

form

atio

n re

quire

d by

the

juris

dict

ion

it op

erat

es?

Doe

s the

ope

ratio

n ha

ve si

gnifi

cant

evi

denc

e th

at th

e in

form

atio

n pr

ovid

ed is

as f

ollo

ws?

Acc

urat

ely

conv

eyed

thro

ugh

labe

ling

or o

ther

acc

urat

e m

arki

ngs o

r co

mm

unic

atio

ns, i

n a

man

ner c

ompl

iant

with

all

rele

vant

re

quire

men

ts;

and

If

prov

ided

by

anot

her m

anuf

actu

rer,

the

info

rmat

ion

is a

s pro

vide

d by

eac

h pr

oduc

t’s m

anuf

actu

rer w

ithou

t mod

ifica

tion

to th

e la

belin

g or

oth

er in

form

atio

n.

Doe

s the

ope

ratio

n ha

ve p

olic

ies a

nd p

roce

dure

s in

plac

e to

seek

cla

rific

atio

n or

cor

rect

ion

of a

ny in

form

atio

n pr

ovid

ed b

y a

man

ufac

ture

r tha

t it h

as re

ason

to

bel

ieve

may

not

acc

urat

e?

☐

☐

☐

C3.

4(a)

• C

anna

bis p

rodu

ct r

ecal

ls –

Doe

s the

ope

ratio

n ha

ve a

n es

tabl

ishe

d po

licy

for c

omm

unic

atin

g a

reca

ll of

a c

anna

bis p

rodu

ct th

at h

as b

een

show

n to

pre

sent

a re

ason

able

or a

rem

ote

prob

abili

ty th

at th

e us

e of

, or e

xpos

ure

to,

the

prod

uct c

ould

cau

se se

rious

adv

erse

hea

lth c

onse

quen

ces,

or c

ould

cau

se

tem

pora

ry o

r med

ical

ly re

vers

ible

adv

erse

hea

lth c

onse

quen

ces?

Doe

s tha

t po

licy

incl

ude

the

follo

win

g?

A

mec

hani

sm to

con

tact

all

cust

omer

s who

hav

e, o

r cou

ld h

ave,

ob

tain

ed th

e pr

oduc

t fro

m th

e op

erat

ion,

incl

udin

g in

form

atio

n on

th

e po

licy

for r

etur

n or

des

truct

ion

of th

e re

calle

d pr

oduc

t;

A m

echa

nism

to c

onta

ct th

e cu

ltiva

tion,

pro

cess

ing

,or

man

ufac

turin

g op

erat

ion

or v

endo

r whi

ch su

pplie

d th

e pr

oduc

t; an

d

Com

mun

icat

ion

and

outre

ach

via

med

ia, a

s nec

essa

ry a

nd

appr

opria

te.

☐

☐

☐

SAMPLE

SAMPLE

Documents

INDUSTRY PROGRAM GUIDE - Amazon Web Servicesamerican-safe-access.s3.amazonaws.com/documents/Talana/Patient... · Industry Program Guide ... Manufacturing, Packaging, ... while teaching