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ID:5336175
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页数:47页
时间:2017-11-23
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1、FDAcGMPInspectionsPekingUniversity2005RobertC.Horan,PhDFDAPharmaceuticalInspectorateNewYorkDistrictFDAInspectionsPeriodic(biennial)comprehensivecGMPPre-ApprovalInspection(PAI)“Forcause”Inspectionmayinvolvemorethanoneassignmentandwillverifycorrectionstopreviousinspections.AllinspectionscoverGMPsFore
2、ignInspectionsbyCountryinFY2004ForeignInspectioninFY2004byFirmTypeFDAcGMPsfor21stCenturyInitiativeAnnounced8/2002;objectivesinclude:EncourageadoptionofnewtechnologiesPromoteindustryuseofmodernqualitysystemapproachesEncouragerisk-basedapproacheswhichfocusoncriticalelementsEnsureFDAreview,compliancean
3、dinspectionpoliciesbasedonstate-of-artpharmaceuticalscienceFDAcGMPsfor21stCenturyInitiativeSystemsBasedInspectionsRisk-BasedApproachtoManufacturingandRegulationPharmaceuticalInspectoratePATGuidancedocument/PATTeamQualitySystemsGuidancedocumentProcessValidation(CompliancePolicyGuiderevised;Guidancebe
4、ingrevised)21CFRPart11ElectronicRecordsGuidance(risk-based;gearedtowardGMPdocuments)PharmaceuticalInspectorateCadreofmostexperiencedinvestigatorswhoarededicatedtodruginspectionsIntensivelytrainedalongwithqualityreviewersandcompliancestaffinFDAheadquarters(HQ)OverallgoalistohavePIworkcloselywithHQper
5、sonnel–moreefficientlyintegratereviewandinspectionfunctionsPharmaceuticalInspectorateFDAReviewstaff,ComplianceOfficersandPIcandidatesattendedtrainingmoduleswhichfocusedon:CurrentRegulatoryProgramsAdvancedQualitySystemsPATandModernPharmaceuticalTechnologyRiskManagementPharmaceuticalInspectorateFieldI
6、nvestigators(18)fromacrossU.S.makeupthePharmaceuticalInspectorateScreeningprocesswithcertificationboardCompletedtrainingwithHQpersonnelOnemonthdetailworkingwithHQstaffLevelIIIcertification(highestlevel)ConductPAIs,complexdruginspectionsProcessAnalyticalTechnologyPATisasystemfordesigning,analyzingand
7、controllingmanufacturingthrough“realtime”measurementsofcriticalqualityattributesofrawandin-processmaterialsandprocesses,withthegoalofensuringfinalproductquality.SeeFDAGuidancedocumentonPATProcessAnaly
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