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ID:46905276
大小:112.00 KB
页数:15页
时间:2019-11-29
《FDAQC实验室检查指南》由会员上传分享,免费在线阅读,更多相关内容在行业资料-天天文库。
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
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