FDA QC实验室检查指南Word文档下载推荐.docx
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FDA QC实验室检查指南Word文档下载推荐.docx
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Thepharmaceuticalqualitycontrollaboratoryservesoneofthemost
importantfunctionsinpharmaceuticalproductionandcontrol.Asignificant
portionoftheCGMPregulations(21CFR211)pertaintothequalitycontrol
laboratoryandproducttesting.Similarconceptsapplytobulkdrugs.
Thisinspectionguidesupplementsotherinspectionalinformationcontained
inotheragencyinspectionalguidancedocuments.Forexample,Compliance
Program7346.832requiringpre-approvalNDA/ANDAinspectionscontains
generalinstructionstoconductproductspecificNDA/ANDAinspectionaudits
tomeasurecompliancewiththeapplicationsandCGMPrequirements.This
includespharmaceuticallaboratoriesusedforin-processandfinished
producttesting.
2.OBJECTIVE
Thespecificobjectivewillbespelledoutpriortotheinspection.The
laboratoryinspectionmaybelimitedtospecificissues,ortheinspection
mayencompassacomprehensiveevaluationofthelaboratory'
scompliancewith
CGMP'
s.Asaminimum,eachpharmaceuticalqualitycontrollaboratoryshould
receiveacomprehensiveGMPevaluationeachtwoyearsaspartofthe
statutoryinspectionobligation.
Ingeneraltheseinspectionsmayinclude
--thespecificmethodologywhichwillbeusedtotestanewproduct
--acompleteassessmentoflaboratory'
sconformancewithGMP'
s
--aspecificaspectoflaboratoryoperations
3.INSPECTIONPREPARATION
FDAInspectionGuidesarebasedontheteaminspectionapproachandour
inspectionofalaboratoryisconsistentwiththisconcept.Aspartofour
efforttoachieveuniformityandconsistencyinlaboratoryinspections,we
expectthatcomplex,highlytechnicalandspecializedtestingequipment,
proceduresanddatamanipulations,aswellasscientificlaboratory
operationswillbeevaluatedbyanexperiencedlaboratoryanalystwith
specializedknowledgeinsuchmatters.
Districtmanagementmakesthefinaldecisionregardingtheassignmentof
personneltoinspections.Nevertheless,weexpectinvestigators,analysts
andotherstoworkasteamsandtoadvisemanagementwhenadditional
expertiseisrequiredtocompleteameaningfulinspection.
Teammembersparticipatinginapre-approvalinspectionmustreadandbe
familiarwithComplianceProgram7346.832,Pre-Approval
Inspections/Investigations.RelevantsectionsoftheNDAorANDAshouldbe
reviewedpriortotheinspection;
butiftheapplicationisnotavailable
fromanyothersource,thisreviewwillhavetobeconductedusingthe
company'
scopyoftheapplication.
Teammembersshouldmeet,ifpossible,priortotheinspectiontodiscuss
theapproachtotheinspection,todefinetherolesoftheteammembers,and
toestablishgoalsforcompletionoftheassignment.Responsibilitiesfor
developmentofallreportsshouldalsobeestablishedpriortothe
inspection.ThisincludesthepreparationoftheFDA483.
TheCenterforDrugEvaluationandResearch(CDER)mayhaveissued
deficiencyletterslistingproblemsthatthesponsormustcorrectpriorto
theapprovalofNDA/ANDA'
sandsupplements.Theinspectionteamisexpected
toreviewsuchlettersonfileatthedistrictoffice,andtheyareexpected
toasktheplantforaccesstosuchletters.Theteamshouldevaluatethe
repliestotheseletterstoassurethatthedataareaccurateandauthentic.
Completetheinspectioneventhoughtherehasbeennoresponsetothese
lettersorwhentheresponseisjudgedinadequate.
4.INSPECTIONAPPROACH
A.General
InadditiontothegeneralapproachutilizedinadrugCGMPinspection,the
inspectionofalaboratoryrequirestheuseofobservationsofthe
laboratoryinoperationandoftherawlaboratorydatatoevaluate
compliancewithCGMP'
sandtospecificallycarryoutthecommitmentsinan
applicationorDMF.Whenconductingacomprehensiveinspectionofa
laboratory,allaspectsofthelaboratoryoperationswillbeevaluated.
Laboratoryrecordsandlogsrepresentavitalsourceofinformationthat
allowsacompleteoverviewofthetechnicalabilityofthestaffandof
overallqualitycontrolprocedures.SOPsshouldbecompleteandadequateand
theoperationsofthelaboratoriesshouldconformtothewrittenprocedures.
Specificationsandanalyticalproceduresshouldbesuitableand,as
applicable,inconformancewithapplicationcommitmentsandcompendial
requirements.
Evaluaterawlaboratorydata,laboratoryproceduresandmethods,laboratory
equipment,includingmaintenanceandca
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