Dietary Supplement CFR Gap Analysis Worksheet

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Section Audit Item Audit EvaluationNotes

Subpart B Personnel Yes No N/A

111.10 (A)

(B1-3)

(4) Procedures for removal of jewelry and other items or appropriate coverings.

(5-6, 8-9)

(7) Change rooms are available and there is adequate storage of personal clothing, etc.

111.12 (A,C) Procedures have been established to define personnel qualifications required for job performance.

(B,C)

111.13 (A) Procedures have been established to define the requirements for personnel who have supervisory responsibilities.

(B) Personnel who are designated as supervisors are qualified.

111.14 (B) Records have been established and maintained for all written procedures.

(2) Records have been established and maintained for all training.

COMMENTS:

DIETARY SUPPLEMENT AUDIT CHECKLIST In Accordance with CFR Title 21 Part 111 & NSF/ANSI 173 Section 8

Procedures have been established that define work requirements for personnel to prevent microbial contamination from illness and/or hygienic practices.

Hygienic practices have been established to include appropriate garments, personal hygiene, hand washing and sanitization, etc. prior to starting work and at any time whereby personnel can become soiled/contaminated.

Procedures for use of impermeable gloves, hairnets, caps, beard covers, etc. and for restrictions on use of food, tobacco, etc. in areas whereby product contamination could occur. Procedures have been established to prevent contamination from all extraneous sources.

Quality Control personnel and responsibilities have been identified and Quality Control personnel are qualified for their assigned responsibilities.

Written job descriptions are available for all personnel and personnel have received GMP and appropriate training for their assigned functions.

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Section Audit Item Audit Evaluation

NotesSubpart C Physical Plant and Grounds Yes No N/A

111.15 (A)(1-3)

(4) Waste treatment and disposal is adequate and does not provide a source of potential contamination.

(5)

(B) Production facility is maintained in a clean and sanitary condition and in a proper state of repair.

Entrances to the facilities are properly controlled and maintained to prevent contamination.

(C)

(D)

Pest control procedures have been established for the appropriate use of any insecticides, fungicides, fumigants, rodenticides, etc.

(E) The water supply is safe and sanitary, under suitable temperature and pressure for its intended use.

(E2)

(F) Plumbing is of adequate size and design for intended usage.

(G)

Floor drainage is adequate (immediate and continuous drainage, no pooling, proper drain covers, etc.)

Grounds have been properly maintained through removal of litter and waste, cutting of grass and weeds adjacent to the plant, maintenance of roads and parking lots, providing adequate drainage, etc.

If applicable, procedures exist for routine inspection of areas that border facility grounds out of the corporate control and not meeting these standards.

Cleaning and sanitizing compounds have been established for cleaning the facility. These cleaning agents are safe and adequate under the conditions of use and are free of microorganisms of publich health significance.

Cleaning and sanitizing agents, pesticide chemicals, and fungicides have been identified, used, held, and stored in a manner that protects against adulteration of raw materials and in-process or finished products, and against contamination of processing equipment, utensils, and packaging materials.

Measures are taken to prevent entrance to the facility by pests and animals, including screens and barriers, rodent traps, insect traps or lights, etc.

Water sources do not act as a potential source of contamination of the dietary supplement, either due to water purity or due to the configuration and construction of the water delivery system.

Water that may contact a component, equipment contact surface, or is used as a component in a dietary supplement meets applicable specifications (minimally Federal, State, and Local requirements).

Potable water, as a minimum quality water, at designated temperature and pressure where appropriate, is provided to all areas where required for processing and cleaning and for employee sanitary facilities. Water meets or exceeds applicable Federal, State, and Local requirements and does not contaminate the dietary supplements.

Sewage and Waste disposal is properly plumbed from the facility and does not provide a potential source of contamination to contact surfaces, products, components, water supplies, etc.

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Subpart C Physical Plant and Grounds (continued) Yes No N/A

Backflow and cross-connection prevention is in place.

(H) Bathrooms are provided and are of adequate number and location.

(I)

Hand washing facilities are constructed and located in appropriate areas to ensure proper hand washing of personnel.

(J) Solid waste and trash are disposed of appropriately and not allowed to accumulate.

Solid waste and trash do not provide a potential source of contamination to components, products, contact surfaces, etc.

(K) Sanitation supervisors have been assigned and are qualified.

111.16 Procedures have been established for cleaning of the plant.

111.20(A) All facilities are of adequate size, construction, and design for their intended use.

(B)

(C) There are adequate precautions against contamination by microorganisms, chemials, filth, or other extraneous materials.

(C1)

(C2)

(C3)

(C4)

(D1) Walls, floors, and ceilings can be adequately cleaning and kept in good repair.

Bathrooms and wash facilities are kept clean and are not a potential source of contamination to components, products, contact surfaces, etc.

Hazardous waste is properly controlled so as not to provide a potential source of contamination to components, products, contact surfaces, etc.

There is adequate space for performing all operations and to prevent mix-ups, contamination, and cross-contamination during manufacturing, packaging, labeling, or holding.

Areas have been clearly defined or separated for receiving, inspecting, and identifying, holding, and withholding from use components, dietary supplements, packaging, and labels that will be used.

Areas have been provided for quarantine and release of materials to be used in the manufacture, packaging, or labeling of dietary supplements.

Areas have been provided to separate the manfuacturing, packaging, labeling, and holding of different product types (e.g. foods, cosmetics, pharmaceuticals) from dietary supplements.

Separate or defined areas exist for laboratory analysis and holding of laboratory supplies and samples, cleaning of contact surfaces, packaging and labeling, and holding of components or dietary supplements.

Fixtures, ducts, piping, etc. are kept clean, do not drip or leak, or provide a source of condensation that could contaminate components, products, or contact surfaces.

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NotesSubpart C Physical Plant and Grounds (continued) Yes No N/A

Adequate ventilation and airflow is provided in all areas of the facility.

Temperature and humidity control equipment is of adequate design for its intended function and is functioning properly.

(E) Adequate lighting is provided in all production areas, examination areas, where equipment is cleaned, etc.

(F)

(G)

(H) Production areas do not provide a haven for pests, pest infestation, filth, etc. (adequate screening and other measures are used).

111.23 (A,B)

(C)

COMMENTS:

Working areas have adequate access to space, aisles are clear, etc. to allow for persons to perform their duties and protect against contamination or mix-ups.

For lighting that is suspended or located above areas where materials or equipment are exposed, it is to be of adequate construction or be of adequate lighting type to prevent contamination (use of safe-lights, fixtures, etc.)

In areas where open vessels are used, there is adequate protection against contamination, e.g. use of protective coverings, physical location, use of skimming equipment, use of screening, etc.

Records have been maintained for plant ceiling, pest control, and water quality (where required) and are in accordance with Subpart P.

Records have been maintained to show that the quality of water, when used as a component of the dietary supplement, meets the requirements of 111.15(e)(2).

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Subpart D Equipment and Utensils Yes No N/A

111.25 (A,B)

(C) Procedures have been established for the cleaning and sanitization of all utensils and equipment.

111.27

(A)

Equipment and utensils protect components and dietary supplements from contamination from any source.

Equipment and utensil surfaces are inspected at routine intervals for signs of wear, damage, etc.

(A5)

(A6)

(A7)

(B,C) Instruments and controls must be calibrated.

(D) All equipment, instruments, utensils, contact surfaces, etc. must be maintained, cleaned, and sanitized as necessary.

(1) Equipment, utensils, etc. must be disassembled as necessary to ensure maintenance, cleaning, and sanitization.

Procedures have been established for calibration of all instruments, controls, automated, mechanical, and electronic equipment, etec.

All equipment and utensils are corrosion resistant, made of non-toxic materials, and of suitable design, construction, and workmanship for their intended use.

Equipment and utensils are of appropriate design so as to not contaminate components, products, or contact surfaces with lubricants, fuel, coolants, metal or glass fragments, filth or any extraneous materials, contaminated water, or other contaminants.

Equipment and utensils are designed and constructed to withstand the environment in which they are used and do not degrade upon exposure to components, process materials, cleaning agents, etc.

Equipment and utensils are constructed as seamless, or if seams exist, are easily cleanable and do not provide a place for accumulation of potential contaminants.

Equipment such as freezers, refrigerators, etc. that are used to hold components or dietary supplements must be functioning properly and adequately designed.

Instruments and controls that are used in all areas must be accurate and precise (calibrated where necessary), maintained, and adequate in number.

Process gases that are used and contact dietary supplements, components, and contact surfaces, must be controlled so as not to cause contamination (e.g. filters).

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NotesSubpart D Equipment and Utensils (continued) Yes No N/A

(2)

(3)

(4) Surfaces that do no come into direct contact with components or dietary supplements are still cleaned.

(5)

(6) Cleaning and sanitizing agents are adequate and safe for their intended use.

(7) Portable equipment and utensils are properly stored after cleaning and sanitization.

111.30 (A-D) Automated, mechanical, or electronic equipment must be functioning properly and are adequately designed.

Automated, mechanical, or electronic equipment must be designed and capable of meeting specifications consistently.

(E) Equipment procedures and controls are in place and have been approved by the Quality Unit.

111.35 (A,B1)

(B2)

(3) Calibration records are kept and available.

(4) Written records are avaiable of calibrations, inspections, and checks of any automated, mechanical, or electronic equipment.

(5) Backup files are an exact and complete record and are secure from alterations, past records, and data that was entered.

(6) Documentation is maintained for any othe control that is used to ensure equipment functions as intended.

COMMENTS:

Low moisture processing: Equipment, utensils, and contact surfaces are dry and sanitized. If wet cleaned, drying and sanitization is performed.

Wet processing: Contact surfaces are cleaned and sanitized before use and after any interruption. If continous production is performed, cleaning and sanitization is performed at designated intervals.

Disposable items (single-service) are stored in appropriate containers; handled, used, dispensed, and disposed of in a manner that protects against contamination.

Automated, mechanical, or electronic equipment must be designed and capable of operating within the operating limits set forth by the manufacturing process.

Written procedures for maintenance, cleaning, sanitization of all equipment, utensils, and contact surfaces are established and records of sanitization are maintained.

Equipment logbooks are maintained for each equipment and includes the date of use, any cleaning documentation, sanitization, maintenance, etc. (unless the documentation is in the batch record).

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Subpart E Production and Process Control System Yes No N/A

111.55 Production and process control systems have been established for each production process and/or product.

111.60

111.65 Quality Control operations have been identified and implemented.

111.70 Specifications have been established for components, in-process materials, labels, packaging, and products.

All specifications are approved by the Quality Unit.

(F)

111.73 A system has been established to determine if all specifications that are established have been met.

111.75(A) Components are samples, tested, and confirmed (released) prior to use in production.

(A) Appropriate tests are conducted to determine if component specifications have been met.

111.75(B,C) Proper procedures have been established to determine if specifications have been met.

(D) One or more product specifcations may be exempted from the verification process if requirements have been met.

(E)

(F1,2)

(G)

(H)

111.77(A)

(B,C) Procedures allow for the Quality Unit to reject any material that does not meet specifications.

Production and processes have been designed to ensure quailty of the product and the Quality Unit has approved the control systems.

Dietary supplements that are supplied for packaging/labeling have specifications for identify and are verified against a purchase order.

If a Certificate of Analysis (COA) is used to confirm the component, the supplier must be qualified and documentation must be maintained for this qualification.

Supplier qualification procedures are established and include initial qualification, periodic examination (requalification), and procedures for disqualification.

For products that are received for packaging and labeling, visual examinations are performed and documentation is available to determine whether the product meets established specifications.

Packaging and labeling materials are visually examined, at a minimum, and are reviewed against the supplier's invoice to determine conformance with specifications.

Packaging and labeling of the finished packaged and labeled dietary supplement are visually examined, at a minimum, to determine that the correct packaging and labeling has been performed.

Scientifically valid methods are used and include at least a gross organoleptic analysis, macroscopic analysis, microscopic analysis, chemical analysis, or another scientifically valid method.

Procedures and controls have been established for investigation and handling of materials that do not meet specification requirements.

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NotesSubpart E Production and Process Control System (continued) Yes No N/A

111.80 Procedures have been established for the collection of representative samples.

(A-E) The representative samples have been collected and meet specification.

111.83 (A,B) Procedures have been established for the collection of reserve samples for each lot of packaged and labeled dietary supplement.

(B) Requirements for reserve samples, including appropriate storage, identification, retain, and testing has been met.

111.87 The Quality Unit conducts all material reviews and disposition decisions.

111.90 (A,B) Procedures have been established for the handling of unexpected events.

Reprocessing controls have been established and meet all specifications.

(C)

111.95 (A,B) Specification records have been maintained.

COMMENTS:

Any batch that has been reprocessed or contains a reprocessed treated, or adjusted component must be approved by the Quality Unit and comply with 111.123(b) prior to release for distribution.

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NotesSubpart F Production and Process Control System: Requirements for Quality Control Yes No N/A

111.103 Procedures have been established for the responsibilities of Quality Control operations.

111.105 Quality Control personnel have established roles and responsibilities.

111.110 Quality Control laboratory operations have been established.

111.113 Quality Control operations and responsibilities have been established for conducting material reviews.

111.113 (B)

(B)

(C)

111.117 Quality Control operations and controls have been established for equipment and instruments.

111.120 Quality Control operations have been established for the control of components, packaging, and labeling.

111.123 (A1-5) Quality Control operations and authority have been established for manufacturing records.

111.123 (A6-8)

111.123 (B) Quality Control has not approved and released product in any form that does not meet the specifications.

111.127 Quality Control operations have been established for packaging and labeling operations.

111.130 Quality Control operations have been established to handle returned dietary supplements.

111.140 (A,B1) The following records have been retained and are also kept in accordance with Subpart P.

111.140 (B2-3) Quality Control operations include written documentation for production reviews, material reviews, and investigations.

Quality Control operations are documented with written documentation and meet all specifications.

The Quality Unit performs cGMP Internal audits periodically. Adocumented corrective action file is maintained.

COMMENTS:

Quality Control operations and responsibilities have included the authority to reject any component or product if any specification is not met.

Quality Control personnel may authorize a treatment, in-process treatment, or reprocessing in an attempt to correct a deviation or unexpected event, or specification deficiency as permitted by 111.77.

The Quality Control person responsible for making the material review and disposition decision has documented the review and disposition decision at the time of performance.

Quality Control operations determine if all specifications have been met (in-process, product) and approval/release or rejection has been performed on each finished batch for distribution.

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NotesSubpart G Yes No N/A

111.153 Written procedures have been established to fufill this Subpart.

111.155 Controls of components have been established.

Raw materials and other ingredients have been evaluated for the presence of naturally occurring toxins.

111.160 (A-D) Quality Control requirements have been estabilished for packaging and labels.

Quality Control inspections and examinations are documented and meet specifications.

111.165

111.170 Rejected components, packaging, labeling, and products are appropriately quarantined.

111.180 Records have been established and are being maintained to meet all specifications.

COMMENTS:

Subpart H Production and Process Control System: Requirements for Master Manufacturing Record Yes No N/A

111.205 (A) Master Manufacturing Records have been prepared for each unique formulation and batch size of the dietary supplement.

(B)

111.210 Master Manufacturing Records contain all of the required elements.

COMMENTS:

Production and Process Control System: Requirements for Components, Packaging, and Labels. Also for Product that is Received for Packaging and Labeling as a Dietary Supplement

Quality Control requirements have been estabilished for products that are received for packaging and labeling as dietary supplements (including for distribution).

Documentation includes date of receipt, initials of personnel performing the required operations, test or examination results, and any material review or disposition decision.

The Master Record identifies specifications for the control points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement.

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NotesSubpart I Production and Process Control System: Requirements for Batch Production Record Yes No N/A

111.255 (A,D) Batch production records are available for each batch of dietary supplement that has been manufactured.

(B) The batch record contains complete information relating to the production of each batch.

(C) The batch recored follows the mater record and each step is performed appropriately.

COMMENTS:

Subpart J Production and Process Control System: Requirements for Laboratory Operations Yes No N/A

111.303 Written procedures have been established for laboratory operations.

111.310 Laboratory facilities are adequate for testing of components, in-process materials, and dietary supplements.

111.315 Laboratory controls have been established and have been approved by the Quality Unit.

Parameters have been set for laboratory controls for sampling plans, criteria for examination and testing methods, etc.

111.320

111.325 Quality Control operations have maintained appropriate records as required.

111.353 Written procedures have been established for manufacturing operations.

COMMENTS:

Quality Control responsibilities for laboratory test methods and examinations used to test each specification requirement have been defined and are being followed.

For all products that bear expiration date or a statement of product shelf life as appropriate or dictated by regulatory authorities, the shelf life must be supported by data.

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NotesSubpart K Production and Process Control System: Requirements for Manufacturing Operations Yes No N/A

111.355 Manufacturing processes have been designed to produce a product that consistently meets specifications.

111.360 Manufacturing operations are conducted using adequate sanitation principles.

111.365 Precautions have been taken to prevent contamination from potential sources.

Manufacturing operations have been established to prevent contamination and adulteration.

Manufacturing operations have included controls in manufacturing steps to prevent contamination.

111.403 Written procedures have been established for all packaging and labeling operations.

(K)

COMMENTS:

Subpart L Production and Process Control System: Requirements for Packaging and Labeling Operations Yes No N/A

111.410 Packaging materials are inspected to determine if they meet the appropriate specifications for the dietary supplements.

(B)

Packaging and labels are controlled for issuance and are reconciled after use.

(C) Packaging and labeling materials are examined before usage to determine that they conform to the Master Manufacturing Record.

(D)

111.415 A Master Manufacturing Record has instructions for filling, assembling, packaging, labeling, and other related operations.

(A) Procedures have been established for cleaning and sanitizing all filling and packaging equipment and utensils.

(D) Physical separation is implemented to prevent mix-ups with other components and dietary supplements.

Manufacturing operations have included the identification of all process lines and major equipment used during manufacturing to indicate their contents, including the name of the dietary supplement and the specific batch or lot number, and when necessary, the phase of manufacturing.

Note: Reconciliation is not necessary for cut or rolled labels when 100% examination is performed by appropriate electronic or electromechanical equipment during or after completion of operations.

Records are maintained to allow a complete history and control of the packaged and labeled dietary supplement through distribution.

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NotesSubpart L Yes No N/A

(B) Filling and packaging operations are appropriately protected from sources of contamination.

(C) Procedures have been established for sanitary handling.

(E) Procedures have been established to identify unlabeled materials that will be held for future labeling operations.

(F) Procedures have been established for assigning a lot or batch number for each lot of packaged and labeled dietary supplement.

(G) Procedures have been established to sample a representative number of units to ensure compliance with specifications.

(H)

111.420(A) All repackaging or relabeling operations have first been approved by the Quality Unit.

(B)

(C) Quality Control Unit has dispositioned each batch or repackaged or relabeled dietary supplement prior to release for distribution.

111.425 An appropriate quarantine system has been established for holding any rejected packaged and labeled dietary supplement.

Storage areas have been demonstrated through testing to meet necessary requirements.

COMMENTS:

Production and Process Control System: Requirements for Packaging and Labeling Operations (continued)

Disposal procedures have been established for disposing of labels or packaging materials that are obsolete or incorrect to ensure that they are not used.

Representative samples of each batch of repackaged or relabeled dietary supplement have been examined to determine if they conform to specifications.

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Subpart M Holding and Distribution Yes No N/A

(B,C)

111.460

111.465

111.475 Procedures have been established for the holding and distribution operations.

COMMENTS:

NSF Recall Procedures Yes No N/A

Written procedures have been established to define the recall of a product.

Mock recalls are conducted on an annual basis.

COMMENTS:

111.453 11.455 (A,C)

Dietary supplements are held under the appropriate conditions of temperature, humidity, and light and do not lead to mix-up, contamination, or deterioration.

Components, packaging, and labeling materials are held under appropriate conditions so they are not adversely affected and do not lead to mix-ups, contamination, or deterioration.

In-process materials that will be held have been identified as to what the appropriate holding conditions (temperature, humidity, light) and are stored under the appropriate conditions to prevent mix-ups, contamination, or deterioration.

Reserve samples are held under the appropriate conditions (as identified by the product) using the same or equivalent container closure system.

Product distribution records have been retained. Records shall be maintained for a period of 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records or 1 year past the shelf life date, if shelf life dating is used.

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Subpart N Return of Dietary Supplements Yes No N/A

111.503 Proceudures have been established for the handling of returned dietary supplements.

111.510 Returned dietary supplements have been appropriately quarantined until dispositioned by the Quality Unit.

111.515

111.520 Any salvaged material has been so designated by the Quality Unit.

111.525

111.530

111.535(A) Written procedures have been established for salvage and reprocessing operations according to Subpart P.

(B)

All Quality Unit evaluations and decisions have been documented.

COMMENTS:

Any returned dietary supplement must be either destroyed or dispoed of unless the Quality Unit has determined that the material can be salvaged or reprocessed.

Any reprocessed material has met its original specification and the Quality Unit has appropriately dispositioned the material (release or reject).

If the reason for a return implicates other batches, an investigation has been performed to determine if those batches comply with specifications.

Documentation has been maintained for material reviews and dispositions. All testing results, any re-evaluations by the Quality Unit for reprocessed materials.

Records shall be maintained for a period of 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records or 1 year past the shelf life date, if shelf life dating is used.

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Subpart O Product Complaints Yes No N/A

Written procedures have been established to describe how product complaints will be received, investigated, and documented.

(A)

(B)

(C) The investigation for a product complaint was appropriately extended to other batches, products, processes, etc.

111.570 (B2)

Product complaint information has included adequate information.

COMMENTS:

Subpart P Records and Record Keeping Yes No N/A

111.605 Procedures have been established that describe the requirements for record retention under Subpart P.

(A)

(B) All records are maintained as original records or as true copies as electronic records.

COMMENTS:

111.553 111.570(B1)

All product complaints have been reviewed by a qualified person to determine if the complaint was the result of a failure of the dietary supplement to meet any of its specifications or quality.

The decision to investigate a complaint as well as the final decision as a result of the investigation has been approved by the Quality Unit.

Written records for each product complaint and investigation related to GMPs have been maintained. Records shall be maintained for a period of 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records or 1 year past the shelf life date, if shelf life dating is used.

Written records will be maintained for 1 year after the shelf life date or 2 years beyond the date of distribution of the last batch associated with those records.

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NotesElectronic Records, Electronic Signatures Yes No N/A

11.10

(A-K) The procedures and controls include adequate information.

11.30

11.50 Electronic signatures conform to requirements.

11.70 Electronic and hand-written signatures have been linked to the electronic record.

11.100 Electronic signatures meet requirements.

11.300 Passwords and codes have been established.

COMMENTS:


NSF Yes No N/A

COMMENTS:

21 CFR Part 11

Procedures and controls have been established for electronic closed systems used to create, modify, maintain, or transmit electronic records in order to ensure the authenticity, integrity, and confidentiality of the records (Closed Systems).

Procedures and controls have been established for use of open electronic systems. Areas of control have been identified, as necessary, per the requirements 11.10.

Compliance with The Public Health Security and Bioterrorism Preparedness and Responst Act of 2002

Manufacturers of dietary supplements shall submit application to USFDA for registration, receive a registration number, and provide the registration number upon request.

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NotesNSF Dietary Supplement and Non-Prescription Drug Consumer Protection Act Yes No N/A

COMMENTS:


ISO ISO 22000 Yes No N/A

Process flow diagrams have been established for all products manufactured and/or packaged.

Appropriate Hazard Analysis for all products has been performed and documented.

Appropriate Critical Control Points have been identified and documented through appropriate documentation.

Corrective Action Preventative Action procedures have been established and are current.

An Organizational Quality Policy is established that defines the overall company philosophy on Quality.

A current organizational chart is established and available for all employees.

COMMENTS:

Written procedures shall be established and followed for reporting serious adverse events to the USFDA in accordance with the Dietary Supplement and Non-Precription Drug Consumer Protection Act.

Documents

Dietary Supplement CFR Gap Analysis Worksheet