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1、GMPandQualitySystemintheUSJimLi,Ph.D.MBAJune29,20102PresentationOverview21CFRPart210and211美國藥品GMP法規(guī)ICHQ7AICH的原料藥指南CGMPprinciplesCGMP基本原則QualitysystemsbasedGMPapproach基于系統(tǒng)的GMP方法FDAcurrentconceptsonprocessvalidation目前FDA對工藝驗證方面的觀點美國藥品GMP法規(guī)21CFRPart210and211321CFRParts210and21121CFRParts210and211GMP
2、Regulationsforfinishedpharmaceuticals:美國藥品生產(chǎn)的GMP法規(guī)Establish“whatto”do,not“howto”法規(guī)建立了藥品生產(chǎn)規(guī)范的基本要求,但未闡明如何做MinimalstandardsMaximumflexibilitySpecificenoughtoaddressproblemsTechnologyneutralScalable4HistoryofCGMPRegulationCGMP法規(guī)的歷史和發(fā)展June1963firstissuedInterpretiveregulationBuildings,Equipment,Person
3、nel,Components,MasterandBatchRecordsProduction/ControlProcedures,ContainersandClosures,PackagingandLabeling,LaboratoryControls,DistributionRecords,Stability,CompliantFilesSept.1978majorrevisionBinding/substantiveregulationArticulatedinPart210SupportedbycaselawExpandedrequirementsWrittenprocedures
4、AutomationControlProcessValidationetcExtensivePreamble緒言Jan.1995,retrospectiveReviewRevisiontoallowflexibilitySeparateanddefinedareasonlyasnecessaryDegreeofcheckingcomputerI/OConditionallyexemptsINDsfromexpirationdatesClarifiesperiodicreviewrequirements5HistoryofCGMPRegulationCGMP法規(guī)的歷史和發(fā)展May1996P
5、roposedRevisionReflectscourtrulingin2/93BarrLabscaseUpdatesregulationstoreflectcurrentindustry:EmphasizeandclarifyprocessvalidationrequirementsClarifyrequirementsforinvestigatingout-of-specificationtestresultsEtc.NeverfinalizedandwithdrawnAug.2002CGMPInitiativeMajorgoalsFocusonpotentialriskstopub
6、lichealthEnsureenforcementdoesnotimpedeinnovationandintroductionofnewtechnologiesEnhanceconsistencyandpredictabilityofFDA’sapproachtoassuringqualityandsafety6Part210:CGMP,General通則210.1StatusofcurrentgoodmanufacturingpracticeregulationsMinimumCGMPrequirementsformethods,facilitiesorcontrols,manufa
7、cture,processing,packing,orholdingofadrugFailurerendersdrugadulterated偽劣HCT/Pssubjectto1271inadditiontoPart211210.2ApplicabilityofCGMPregulations.Parts211-226,600-680and1271consideredtosupplement,Applicabletotheoperati
