FDA QC实验室检查指南

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1、GUIDETOINSPECTIONSOFPHARMACEUTICALQUALITYCONTROLLABORATORIESNote:ThisdocumentisreferencematerialforinvestigatorsandotherFDApersonnel.ThedocumentdoesnotbindFDA,anddoesnoconferanyrights,privileges,benefits,orimmunitiesfororonanyperson(s).1.INTRODUCTIONTheph

2、armaceuticalqualitycontrollaboratoryservesoneofthemostimportantfunctionsinpharmaceuticalproductionandcontrol.AsignificantportionoftheCGMPregulations(21CFR211)pertaintothequalitycontrollaboratoryandproducttesting.Similarconceptsapplytobulkdrugs.Thisinspect

3、ionguidesupplementsotherinspectionalinformationcontainedinotheragencyinspectionalguidancedocuments.Forexample,ComplianceProgram7346.832requiringpre-approvalNDA/ANDAinspectionscontainsgeneralinstructionstoconductproductspecificNDA/ANDAinspectionauditstomea

4、surecompliancewiththeapplicationsandCGMPrequirements.Thisincludespharmaceuticallaboratoriesusedforin-processandfinishedproducttesting.2.OBJECTIVEThespecificobjectivewillbespelledoutpriortotheinspection.Thelaboratoryinspectionmaybelimitedtospecificissues,o

5、rtheinspectionmayencompassacomprehensiveevaluationofthelaboratory'scompliancewithCGMP's.Asaminimum,eachpharmaceuticalqualitycontrollaboratoryshouldreceiveacomprehensiveGMPevaluationeachtwoyearsaspartofthestatutoryinspectionobligation.Ingeneraltheseinspect

6、ionsmayinclude--thespecificmethodologywhichwillbeusedtotestanewproduct--acompleteassessmentoflaboratory'sconformancewithGMP's--aspecificaspectoflaboratoryoperations3.INSPECTIONPREPARATIONFDAInspectionGuidesarebasedontheteaminspectionapproachandourinspecti

7、onofalaboratoryisconsistentwiththisconcept.Aspartofourefforttoachieveuniformityandconsistencyinlaboratoryinspections,weexpectthatcomplex,highlytechnicalandspecializedtestingequipment,proceduresanddatamanipulations,aswellasscientificlaboratoryoperationswil

8、lbeevaluatedbyanexperiencedlaboratoryanalystwithspecializedknowledgeinsuchmatters.Districtmanagementmakesthefinaldecisionregardingtheassignmentofpersonneltoinspections.Nevertheless,weexpectinvestigators,analystsando