FDAQC实验室检查指南

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

2、ryservesoneofthemostimportantfunctionsinpharmaceuticalproductionandcontrol.AsignificantportionoftheCGMPregulations(21CFR211)pertaintothequalitycontrollaboratoryandproducttesting.Similarconceptsapplytobulkdrugs.Thisinspectionguidesupplementsotherinspectionalinformationcontainedinotheragency

3、inspectionalguidancedocuments.Forexample,ComplianceProgram7346.832requiringpre-approvalNDA/ANDAinspectionscontainsgeneralinstructionstoconductproductspecificNDA/ANDAinspectionauditstomeasurecompliancewiththeapplicationsandCGMPrequirements.Thisincludespharmaceuticallaboratoriesusedforin-pro

4、cessandfinishedproducttesting.2.OBJECTIVEThespecificobjectivewillbespelledoutpriortotheinspection.Thelaboratoryinspectionmaybelimitedtospecificissues,ortheinspectionmayencompassacomprehensiveevaluationofthelaboratory'scompliancewithCGMP's.Asaminimum,eachpharmaceuticalqualitycontrollaborato

5、ryshouldreceiveacomprehensiveGMPevaluationeachtwoyearsaspartofthestatutoryinspectionobligation.Ingeneraltheseinspectionsmayinclude--thespecificmethodologywhichwillbeusedtotestanewproduct--acompleteassessmentoflaboratory'sconformancewithGMP's--aspecificaspectoflaboratoryoperations3.INSPECTI

6、ONPREPARATIONFDAInspectionGuidesarebasedontheteaminspectionapproachandourinspectionofalaboratoryisconsistentwiththisconcept.Aspartofourefforttoachieveuniformityandconsistencyinlaboratoryinspections,weexpectthatcomplex,highlytechnicalandspecializedtestingequipment,proceduresanddatamanipulat

7、ions,aswellasscientificlaboratoryoperationswillbeevaluatedbyanexperiencedlaboratoryanalystwithspecializedknowledgeinsuchmatters.Districtmanagementmakesthefinaldecisionregardingtheassignmentofpersonneltoinspections.Nevertheless,weexpectinvestigators,analysts..a