BT 201BT 201

Biotechnology Techniques IBiotechnology Techniques I

Record Keeping and Record Keeping and NotebooksNotebooks

Quality SystemsQuality Systems Many laboratories are concerned with qualityMany laboratories are concerned with quality Biotechnology industries are concerned with Biotechnology industries are concerned with

product qualityproduct quality Clinical labs are concerned with quality of test Clinical labs are concerned with quality of test

results and instrument performanceresults and instrument performance Research labs are concerned with quality of Research labs are concerned with quality of

knowledgeknowledge Quality systemsQuality systems help ensure product quality help ensure product quality

– Organizational structure, responsibilities, Organizational structure, responsibilities, procedures, processes, and resources that together procedures, processes, and resources that together ensure the quality of a product or serviceensure the quality of a product or service

Quality in Research LabsQuality in Research Labs

Thought of more as “doing good Thought of more as “doing good science”science”

Consistent, thoughtful, and effective Consistent, thoughtful, and effective methodsmethods

Keeping honest and thorough records Keeping honest and thorough records Verifying all results and employing Verifying all results and employing

“good laboratory practices”“good laboratory practices” Scientists submit results of work to Scientists submit results of work to

journals to be subjected to peer reviewjournals to be subjected to peer review

Quality in Regulated Quality in Regulated CompaniesCompanies

Strict enforcement of quality in industryStrict enforcement of quality in industry cGMPscGMPs (current Good Manufacturing (current Good Manufacturing

Practices) are used in drug and related Practices) are used in drug and related medical product producing companiesmedical product producing companies– Covers everyone from makers of medical Covers everyone from makers of medical

products to people who distribute, package, sell products to people who distribute, package, sell or use the itemsor use the items

GMPs are formalized into GMPs are formalized into regulationsregulations– Requirements that government-sanctioned Requirements that government-sanctioned

agencies impose on an industry and companies agencies impose on an industry and companies within that industrywithin that industry

RegulationsRegulations

Objective and focus on safety, efficacy, Objective and focus on safety, efficacy, honestyhonesty

Don’t cover subjective areas of qualityDon’t cover subjective areas of quality Imposed by the government acting on Imposed by the government acting on

behalf of the consumerbehalf of the consumer Laws that are enforced by the Laws that are enforced by the

governmentgovernment Industries are required to complyIndustries are required to comply

Quality in Regulated Quality in Regulated CompaniesCompanies

GLPs (Good Laboratory Practices) governing labs GLPs (Good Laboratory Practices) governing labs that use animals to test drug safetythat use animals to test drug safety

EPA uses GLPs governing agrochemical product EPA uses GLPs governing agrochemical product testingtesting

CLIA ’88 (The Clinical Laboratory Improvement CLIA ’88 (The Clinical Laboratory Improvement Amendments of 1988) is a system of regulations Amendments of 1988) is a system of regulations intended to ensure quality of results generated intended to ensure quality of results generated by labs performing tests on human specimensby labs performing tests on human specimens

Helps ensure trust in quality of medical test Helps ensure trust in quality of medical test resultsresults

Quality With Voluntary Quality With Voluntary StandardsStandards

Biotech companies making products not Biotech companies making products not regulated by government may choose to regulated by government may choose to comply with voluntary comply with voluntary quality standardsquality standards– Enzymes and other molecular biology reagents Enzymes and other molecular biology reagents

used in research labs fall into this categoryused in research labs fall into this category– StandardStandard is a concept, method, or way of doing is a concept, method, or way of doing

things that is established by some authority, by things that is established by some authority, by custom, or by general agreementcustom, or by general agreement Established by various organizations, agencies, and Established by various organizations, agencies, and

other entitiesother entities Not law, not government enforced, compliance Not law, not government enforced, compliance

voluntaryvoluntary

Quality StandardsQuality Standards Some standards are subjectiveSome standards are subjective Some standards are objectiveSome standards are objective Some standards are broad in scope intended to ensure quality of Some standards are broad in scope intended to ensure quality of

final productsfinal products ISO (International Organization for Standardization) 9000ISO (International Organization for Standardization) 9000

is a series of quality standardsis a series of quality standards Many companies follow ISO 9000 standards to improve product Many companies follow ISO 9000 standards to improve product

quality, make processes cost-effective, increase profitability, quality, make processes cost-effective, increase profitability, demonstrate quality manufacturing to potential customersdemonstrate quality manufacturing to potential customers

Can be applied to any company that makes a product or even one Can be applied to any company that makes a product or even one that provides a servicethat provides a service

Companies develop and follow their own quality plan with ISO Companies develop and follow their own quality plan with ISO 90009000– Formalized and documented in quality manualFormalized and documented in quality manual– Hires certified auditor to evaluate their statusHires certified auditor to evaluate their status– If they are in compliance and all parts of quality program exist, they If they are in compliance and all parts of quality program exist, they

will be ISO certifiedwill be ISO certified ISO Guide 25 focuses on lab specific issues, similar to ISO 9000ISO Guide 25 focuses on lab specific issues, similar to ISO 9000

Quality DocumentsQuality Documents

GMP regulations and ISO documents written GMP regulations and ISO documents written in very general termsin very general terms– To be applicable across a broad range of labs, To be applicable across a broad range of labs,

organizations, and companiesorganizations, and companies– Do not give specifics about implementation of Do not give specifics about implementation of

quality system or planquality system or plan FDA interprets and enforces GMP FDA interprets and enforces GMP

requirements in guidance documents called requirements in guidance documents called “Guidelines” and “Points to Consider”“Guidelines” and “Points to Consider”– Not law, these are intended to help companies Not law, these are intended to help companies

apply GMP principles to their own situationapply GMP principles to their own situation

Common Elements of Quality Common Elements of Quality SystemsSystems

Quality systems have elements in commonQuality systems have elements in common DocumentationDocumentation consists of written records that guide activities consists of written records that guide activities

and substantiate and prove what occurredand substantiate and prove what occurred– Documentation is a cornerstone of good quality systemsDocumentation is a cornerstone of good quality systems– Written procedures ensure consistencyWritten procedures ensure consistency– Written records show who did what, and when, provides Written records show who did what, and when, provides

accountabilityaccountability– Common sayings about documentation and record keepingCommon sayings about documentation and record keeping

““If it isn’t written down, it wasn’t done”If it isn’t written down, it wasn’t done” ““Do what you say and say what you do”Do what you say and say what you do”

ResourcesResources are another common quality element are another common quality element– All labs need resources, regardless of typeAll labs need resources, regardless of type

Skilled personnelSkilled personnel are one of most important are one of most important– Employer’s responsibility to ensure all employees have necessary education Employer’s responsibility to ensure all employees have necessary education

and training for adequate and appropriate performance under all and training for adequate and appropriate performance under all circumstancescircumstances

– Records show qualifications, track training, education, acquisition of new skillsRecords show qualifications, track training, education, acquisition of new skills– Employees are responsible for accuracy and completeness of their own work Employees are responsible for accuracy and completeness of their own work

and accountability for their actionsand accountability for their actions– Following instructions, documentation of work, observation of problems and Following instructions, documentation of work, observation of problems and

appropriate reporting, understanding impact and consequences of their appropriate reporting, understanding impact and consequences of their actions, and undergoing continuoustrainingactions, and undergoing continuoustraining

Facilities, equipment, instruments, and raw materialsFacilities, equipment, instruments, and raw materials are resources are resources necessary for productionnecessary for production

– Facilities must be sufficiently equipped for all activities occurring within, be Facilities must be sufficiently equipped for all activities occurring within, be appropriately sized, maintain necessary environmentappropriately sized, maintain necessary environment

Management of ChangeManagement of Change One of the most important and difficult One of the most important and difficult

aspects of quality systems in a aspects of quality systems in a manufacturing environment is managing manufacturing environment is managing changechange

Changes must be reviewed, evaluated, and Changes must be reviewed, evaluated, and approved before and after they are madeapproved before and after they are made– Require detailed assessment and evaluationRequire detailed assessment and evaluation

Some changes must be approved by proper Some changes must be approved by proper regulatory agency for regulated companiesregulatory agency for regulated companies

Change must be controlled and done in a Change must be controlled and done in a procedural mannerprocedural manner

Management of ChangeManagement of Change Each lab, facility, or organization should have a Each lab, facility, or organization should have a

procedure for changeprocedure for change– Non-research environments usually have SOP Non-research environments usually have SOP

outlining change processoutlining change process Change should always be justifiedChange should always be justified In a manufacturing facility, proposed changes should In a manufacturing facility, proposed changes should

be evaluated and pre-approved by R&Dbe evaluated and pre-approved by R&D A technical review of the proposed change should be A technical review of the proposed change should be

performed to assess its value, and to address risks performed to assess its value, and to address risks associated with the changeassociated with the change

In a regulated company the QC/QA unit must review In a regulated company the QC/QA unit must review the change to see if it requires approval by regulatory the change to see if it requires approval by regulatory agenciesagencies

If necessary, the change should be evaluated for If necessary, the change should be evaluated for financial implicationsfinancial implications

After the change is made its effects should be After the change is made its effects should be investigated and documentedinvestigated and documented

DocumentationDocumentation Defined most simply as a system of Defined most simply as a system of

recordsrecords Essential to any quality systemEssential to any quality system Adequate documentation must be Adequate documentation must be

maintained to satisfy requirements of maintained to satisfy requirements of regulatory agencies and laws along with regulatory agencies and laws along with voluntary standards that a facility voluntary standards that a facility chooses to comply withchooses to comply with

Important in all settings, from Important in all settings, from manufacturing to research to clinicalmanufacturing to research to clinical

DocumentationDocumentation

FDA says “if it isn’t written down, it isn’t done”FDA says “if it isn’t written down, it isn’t done”– Any documentation that is missing will prohibit the sale Any documentation that is missing will prohibit the sale

of that batch of productof that batch of product– Documents associated with products must be Documents associated with products must be

completed, stored securely, and protected completed, stored securely, and protected Research must be appropriately documented to Research must be appropriately documented to

be crediblebe credible Documentation protects personnel in the event of Documentation protects personnel in the event of

future questions regarding procedure, quality, future questions regarding procedure, quality, safety, equipment functionality regardless of safety, equipment functionality regardless of facilityfacility

Functions of DocumentationFunctions of Documentation To record what the individual has done and observedTo record what the individual has done and observed To establish ownership for patent purposesTo establish ownership for patent purposes To tell workers how to perform particular tasksTo tell workers how to perform particular tasks To establish specifications by which to evaluate a process or To establish specifications by which to evaluate a process or

productproduct To demonstrate that a procedure was performed correctlyTo demonstrate that a procedure was performed correctly To record operating parameters of a lab instrument or To record operating parameters of a lab instrument or

manufacturing vesselmanufacturing vessel To demonstrate and evidence “trail” that a product meets its To demonstrate and evidence “trail” that a product meets its

requirementsrequirements To ensure To ensure traceabilitytraceability: the ability to trace the history, : the ability to trace the history,

applications, and location of a product and to trace the applications, and location of a product and to trace the components of a productcomponents of a product

To establish a contract between a company and consumersTo establish a contract between a company and consumers To establish a contract between a company and regulatory To establish a contract between a company and regulatory

agenciesagencies

Types of DocumentsTypes of Documents

Documentation types and systems vary Documentation types and systems vary depending on the workplacedepending on the workplace

Research labs primarily use lab Research labs primarily use lab notebooksnotebooks

SOPs that describe how to perform SOPs that describe how to perform specific tasks are used in production specific tasks are used in production facilitiesfacilities

Some documents may be used in both Some documents may be used in both research and production facilitiesresearch and production facilities

Types of DocumentationTypes of Documentation Lab notebooks: chronological log of everything that an individual does in a Lab notebooks: chronological log of everything that an individual does in a

lablab SOPs detail how to complete a specific task and how to document that the SOPs detail how to complete a specific task and how to document that the

task was done correctlytask was done correctly Forms contain blanks that are filled out by an operator to record informationForms contain blanks that are filled out by an operator to record information

– Typically associated with SOPs or other documentsTypically associated with SOPs or other documents Protocols are similar to SOPs except usually apply where hypotheses are Protocols are similar to SOPs except usually apply where hypotheses are

being tested or procedure is going to be performed only one timebeing tested or procedure is going to be performed only one time Reports are documents generated during protocol executionReports are documents generated during protocol execution Equipment/Instrument logbooks keep track of maintenance, calibration, and Equipment/Instrument logbooks keep track of maintenance, calibration, and

problems for a given instrument or piece of equipmentproblems for a given instrument or piece of equipment Recordings from instrumentsRecordings from instruments Electronic documentsElectronic documents Analytical lab documents that record information regarding sample testing Analytical lab documents that record information regarding sample testing Numbering systems like lot number assignments to keep tract of materials, Numbering systems like lot number assignments to keep tract of materials,

equipment, or productsequipment, or products Labels attached to solutions, products, or items to identify themLabels attached to solutions, products, or items to identify them Chain of custody forms used to trace movement of a sample throughout a Chain of custody forms used to trace movement of a sample throughout a

facility and to keep samples and test results from being confused with one facility and to keep samples and test results from being confused with one anotheranother

Training reports document that individual employees were properly trained Training reports document that individual employees were properly trained to perform particular tasksto perform particular tasks

Production Facility Specific Production Facility Specific DocumentsDocuments

Batch records are collections of documents Batch records are collections of documents associated with a particular batch of a associated with a particular batch of a productproduct

Regulatory submissions are forms filled out Regulatory submissions are forms filled out and sent to regulatory agencies to inform and sent to regulatory agencies to inform them of what a company is planning and /or them of what a company is planning and /or to ask permission to test or sell a productto ask permission to test or sell a product

Release of final product record is filled out Release of final product record is filled out when a product has been approved for salewhen a product has been approved for sale

Laboratory NotebooksLaboratory Notebooks Assigned to individuals and are a Assigned to individuals and are a

chronological log of everything that chronological log of everything that individual does and observes in the individual does and observes in the laboratorylaboratory

Should be complete enough you or another Should be complete enough you or another person could exactly repeat your work person could exactly repeat your work based on information in the notebookbased on information in the notebook

Most widely used form of documentation in Most widely used form of documentation in laboratorieslaboratories

Most important in a research labMost important in a research lab

Typical Notebook FormatTypical Notebook Format Inside front of the notebook should have an ID number for the notebook, the person to whom it is assigned, Inside front of the notebook should have an ID number for the notebook, the person to whom it is assigned,

date of assignment, the project, company and any other identifying informationdate of assignment, the project, company and any other identifying information Table of contents on the first pageTable of contents on the first page

– Including page numbers and descriptions with sufficient detail to allow easy searching of the notebook’s contentsIncluding page numbers and descriptions with sufficient detail to allow easy searching of the notebook’s contents A page number on every page in consecutive orderA page number on every page in consecutive order A thorough listing of the results of any literature search and experimental information from colleagues for each A thorough listing of the results of any literature search and experimental information from colleagues for each

projectproject Dates, titles, and descriptionsDates, titles, and descriptions

– Begin each day’s record with date, title, and description of objectives for the dayBegin each day’s record with date, title, and description of objectives for the day– Draw diagonal lines across unused parts of the previous day’s pageDraw diagonal lines across unused parts of the previous day’s page

Dates and signatures on each pageDates and signatures on each page– In some labs a witness must read, sign, and date each page, along with the person doing the workIn some labs a witness must read, sign, and date each page, along with the person doing the work– The scientist and witness should verify that there are no blank spaces, all tables are complete, and that the page is completeThe scientist and witness should verify that there are no blank spaces, all tables are complete, and that the page is complete– Corrections made later should be signed and dated by scientist and the witnessCorrections made later should be signed and dated by scientist and the witness

The rationale for each activity performedThe rationale for each activity performed Relevant equations or calculationsRelevant equations or calculations Complete descriptions of all instrumentation (including models and serial numbers), chemicals used (including Complete descriptions of all instrumentation (including models and serial numbers), chemicals used (including

manufacturers, catalog and lot numbers, expiration dates) supplies used (with a complete description) samples manufacturers, catalog and lot numbers, expiration dates) supplies used (with a complete description) samples assayed (including complete descriptions and sample identification numbers), standards or reference materials assayed (including complete descriptions and sample identification numbers), standards or reference materials used, etc.used, etc.

Procedural detailsProcedural details– If an SOP or protocol is followed it should be referenced in a manner so that it can be identifiedIf an SOP or protocol is followed it should be referenced in a manner so that it can be identified– Any deviations or justification should be notedAny deviations or justification should be noted– If procedure is from print source, like book or journal, etc. the complete reference for the procedure should be cited and If procedure is from print source, like book or journal, etc. the complete reference for the procedure should be cited and

procedural details may need to be recorded as wellprocedural details may need to be recorded as well DataData

– Take many formsTake many forms– Instrument print-outs may be affixed with a permanent adhesiveInstrument print-outs may be affixed with a permanent adhesive– Print-outs should be titled and dated so they can be replaced in the notebook, if necessaryPrint-outs should be titled and dated so they can be replaced in the notebook, if necessary

If not affixed to notebook, they should be checked, titled, signed, dated, filed, and referenced clearly in the notebookIf not affixed to notebook, they should be checked, titled, signed, dated, filed, and referenced clearly in the notebook Observations may include chanegs in pH, temperature, instrument operational paramatersObservations may include chanegs in pH, temperature, instrument operational paramaters A brief summary of the work completedA brief summary of the work completed A conclusion and brief interpretation of data collecetd may be neededA conclusion and brief interpretation of data collecetd may be needed

– For example, if investigation ifs pursued based on preliminary resultsFor example, if investigation ifs pursued based on preliminary results– Avoid negative or extraneous commentsAvoid negative or extraneous comments

Notebook GuidelinesNotebook Guidelines Use only a bound notebookUse only a bound notebook Number every page consecutively prior to using the notebookNumber every page consecutively prior to using the notebook Never rip out a pageNever rip out a page Make all entries in ink (preferably black)Make all entries in ink (preferably black) Use legible, clear, complete writingUse legible, clear, complete writing Enter all observations and data immediately and directly into the Enter all observations and data immediately and directly into the

notebooknotebook Cross out errors with a single line, initial and dateCross out errors with a single line, initial and date

– Never attempt to erase or cover completely, do not scribble over or use Never attempt to erase or cover completely, do not scribble over or use correction fluidcorrection fluid

Note all problems; never try to hide or ignore mistakesNote all problems; never try to hide or ignore mistakes Be honest and objective, don’t editorialize Be honest and objective, don’t editorialize Cross out blank lines or blank pages with diagonal lines to avoid Cross out blank lines or blank pages with diagonal lines to avoid

changes being added laterchanges being added later Always include detailed information about reagents, instruments, Always include detailed information about reagents, instruments,

samples, materials, and equipment usedsamples, materials, and equipment used– Be able to account for and trace all materials usedBe able to account for and trace all materials used

Store your notebook in a secure locationStore your notebook in a secure location

Considerations for Considerations for NotebooksNotebooks

Write it down! If you did it, record itWrite it down! If you did it, record it Procedures can be pasted into notebooks Procedures can be pasted into notebooks

if it is the first time they are used, if it is the first time they are used, referenced after thatreferenced after that

Keep it as neat as possibleKeep it as neat as possible Be clear and concise; no need for Be clear and concise; no need for

unnecessary writingunnecessary writing Include all appropriate materials/sectionsInclude all appropriate materials/sections

SOPsSOPs

Detail how to complete a task; what all is Detail how to complete a task; what all is involvedinvolved

Preliminary work must be done before Preliminary work must be done before writing an SOP, like listing important writing an SOP, like listing important characteristics of final productcharacteristics of final product

What considerations contribute to quality What considerations contribute to quality should be evaluated and describedshould be evaluated and described

It should be determined if particular It should be determined if particular brands or grades of materials should be brands or grades of materials should be used in a procedureused in a procedure

SOP GuidelinesSOP Guidelines SOPs must be reviewed and accepted before useSOPs must be reviewed and accepted before use The writer has to sign it and accept responsibility The writer has to sign it and accept responsibility

for itfor it A second individual knowledgeable about the A second individual knowledgeable about the

work also approves and signswork also approves and signs In companies a QA employee also signs itIn companies a QA employee also signs it SOPs may require changesSOPs may require changes Old SOPs must be destroyed or made unavailable Old SOPs must be destroyed or made unavailable

when changes are made except for historical when changes are made except for historical copiescopies

Changes may need to go through several levels Changes may need to go through several levels for acceptancefor acceptance

Each revision needs a date and revision numberEach revision needs a date and revision number

SOP ComponentsSOP Components TitleTitle AuthorAuthor Statement of purposeStatement of purpose ID number and dateID number and date Revision number, date of revisionRevision number, date of revision Statement of scope describing when procedure is relevantStatement of scope describing when procedure is relevant Who is qualified to follow the procedure, statement of Who is qualified to follow the procedure, statement of

responsibilityresponsibility Materials required, including manufacturers and identifying Materials required, including manufacturers and identifying

informationinformation Calculations required, may need an exampleCalculations required, may need an example Steps in the processSteps in the process References to other documents, as requiredReferences to other documents, as required How to document performance and references to formsHow to document performance and references to forms

Potential SOP Problems Potential SOP Problems

SOP says what to do, not how to do itSOP says what to do, not how to do it Procedure written by someone Procedure written by someone

inexperienced inexperienced SOP is too detailed or not detailed SOP is too detailed or not detailed

enoughenough Procedure not written in correct orderProcedure not written in correct order SOP not updated as neededSOP not updated as needed Right SOP can’t be found or older version Right SOP can’t be found or older version

is usedis used

FormsForms

Often used in conjunction with SOP Often used in conjunction with SOP and filled in as procedure is followedand filled in as procedure is followed

Blanks must be filled in as employee Blanks must be filled in as employee goes along, requiring them to monitor goes along, requiring them to monitor their processtheir process

Serves as a reminder to record Serves as a reminder to record necessary informationnecessary information

Some key steps may need to be Some key steps may need to be signedsigned

ProtocolsProtocols

Some industries used the term to Some industries used the term to describe a procedure that tells an describe a procedure that tells an operator how to perform a task or an operator how to perform a task or an experiment that is intended to answer experiment that is intended to answer a question or test a hypothesisa question or test a hypothesis

May also be used to describe a May also be used to describe a procedure that may only be used one procedure that may only be used one timetime

Protocols typically lead to an answer, Protocols typically lead to an answer, SOPs give procedural directionsSOPs give procedural directions

Protocol ComponentsProtocol Components The hypothesis or question the study is designed The hypothesis or question the study is designed

to answerto answer Description of the studyDescription of the study

– Protocol may reference SOPsProtocol may reference SOPs Plan for conducting the studyPlan for conducting the study Information about sample collection, processing, Information about sample collection, processing,

and identificationand identification Methods needed to test the hypothesisMethods needed to test the hypothesis Testing scheduleTesting schedule How study results and conclusions will be How study results and conclusions will be

reportedreported Criteria to be used to reach conclusionsCriteria to be used to reach conclusions

ReportsReports

Document that describes the results of Document that describes the results of an executed protocolan executed protocol

What was done, by whom, why, data What was done, by whom, why, data obtained, conclusions drawnobtained, conclusions drawn

Written in narrative formatWritten in narrative format Scientific research published in journalsScientific research published in journals Private company investigation reports Private company investigation reports

may not be published but are required may not be published but are required to be available for inspectionto be available for inspection

Logbooks and Instrument Logbooks and Instrument RecordingsRecordings

Logbooks are chronological records about Logbooks are chronological records about status and maintenance of equipment or status and maintenance of equipment or instrumentsinstruments

Instruments may generate automatic result Instruments may generate automatic result printoutsprintouts– Considered to be raw dataConsidered to be raw data– May be affixed to notebooks or filedMay be affixed to notebooks or filed– Some instruments continuously monitor Some instruments continuously monitor

themselves and record parameters as they operatethemselves and record parameters as they operate– Must be thoroughly identified and be signed and Must be thoroughly identified and be signed and

dated by techniciandated by technician

Electronic DocumentationElectronic Documentation

Used to control and monitor Used to control and monitor instrumentsinstruments

Recording and analysis of dataRecording and analysis of data Storage of protocols and SOPsStorage of protocols and SOPs Printouts, disks, other media may be Printouts, disks, other media may be

generated by computersgenerated by computers Appropriate security and validity of Appropriate security and validity of

electronic documentation must be electronic documentation must be established for it to be of valueestablished for it to be of value

Analytical Lab DocumentsAnalytical Lab Documents

Analytical labs measure properties of Analytical labs measure properties of a samplea sample

Environmental labs, clinical labs, Environmental labs, clinical labs, reference labsreference labs

Documentation must be provided Documentation must be provided concerning methodology used and concerning methodology used and sample identificationsample identification

Necessary Analytical Lab Necessary Analytical Lab InformationInformation

Assay method informationAssay method information– Test purposeTest purpose– Test limitsTest limits– Test method originTest method origin– Validation informationValidation information– Suitability of testSuitability of test

Sample informationSample information– ID numberID number– Collection method and detailsCollection method and details– Storage location and conditionsStorage location and conditions– Disposition informationDisposition information

Assay informationAssay information– Sample testedSample tested– Test dateTest date– Who performed testWho performed test– Reagents and materials usedReagents and materials used– Method used for testMethod used for test– Raw data collectedRaw data collected– Calculations for resultsCalculations for results– Reported conclusions based on the testReported conclusions based on the test

Identification Numbers and Identification Numbers and LabelsLabels

ID numbers used to uniquely identify itemsID numbers used to uniquely identify items Raw materials, documents, equipment, Raw materials, documents, equipment,

parts, product batches, chemicals, parts, product batches, chemicals, solutions, lab samplessolutions, lab samples

Tells what it is and which one in the set it isTells what it is and which one in the set it is Labels identify equipment, materials, Labels identify equipment, materials,

products, other itemsproducts, other items Have various types of informationHave various types of information

Label ComponentsLabel Components

Preparation datePreparation date Person responsiblePerson responsible ID numberID number Lot numberLot number Identity, composition, or name of the Identity, composition, or name of the

itemitem Safety informationSafety information Name of company or institutionName of company or institution Storage and stability informationStorage and stability information

Chain of CustodyChain of Custody

Provides a paper trail for samplesProvides a paper trail for samples Used to organize information about samplesUsed to organize information about samples Each sample has a unique ID numberEach sample has a unique ID number Records show sample source, collector, Records show sample source, collector,

transporter, condition upon receipt, date of transporter, condition upon receipt, date of receipt, sample processing and testing receipt, sample processing and testing methods and personnel, storage information, methods and personnel, storage information, dispositiondisposition

Every move along the process must be Every move along the process must be loggedlogged

Training ReportsTraining Reports

Keep track of individuals who have Keep track of individuals who have been trained in a facilitybeen trained in a facility

Shoe what training has been Shoe what training has been completedcompleted

Dates of trainingDates of training Purpose of trainingPurpose of training Demonstrates who is competent to Demonstrates who is competent to

perform jobperform job

Production Facility Specific Production Facility Specific DocumentsDocuments

Batch recordsBatch records– Accompany a particular batch or Accompany a particular batch or

product, directing the process by which product, directing the process by which a product is to be made, raw materials a product is to be made, raw materials required, SOPs to followrequired, SOPs to follow

– Stays with product as it is madeStays with product as it is made– Includes blanks to be filled in as Includes blanks to be filled in as

procedures are performedprocedures are performed– Must be complete, readable, correctMust be complete, readable, correct

Batch Record ComponentsBatch Record Components Product identificationProduct identification Document identificationDocument identification Company nameCompany name Dates of manufacturingDates of manufacturing Step by step account of processing and Step by step account of processing and

testing to be donetesting to be done Monitoring specificationsMonitoring specifications Raw data to be collected and blanks to Raw data to be collected and blanks to

record it inrecord it in Materials and equipment to be usedMaterials and equipment to be used Required signaturesRequired signatures

Regulatory Submissions & Regulatory Submissions & Release of Final Product Release of Final Product

RecordsRecords Regulatory submissionsRegulatory submissions are completed are completed

to meet the requirements of an outside to meet the requirements of an outside regulatory agencyregulatory agency– Ask for permission, report activityAsk for permission, report activity

Release documentsRelease documents are completed to are completed to show when a product has been show when a product has been manufactured and testedmanufactured and tested– Certifies the product, shows specifications, Certifies the product, shows specifications,

established the documentation has been established the documentation has been reviewed and approved, state the product is reviewed and approved, state the product is ready to be soldready to be sold

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