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1、RegulationsforHandlingSamplesandLaboratoryTestingfromR&DthroughPhaseIIIClinicalTrialsRonHinkel,DirectorQualitySystemsBioRelianceInc.PattiRossman,PresidentGlobioxPurpose?Keeppacewithcurrentregulatoryinterpretation.?Helpmanage/positiontestingperformedduringthedrugdevelopmentlifecycleregardingregula
2、toryinterpretation.Scope?GuidelineforRegulationsusedto:–Standardizeinternaloperations–Provideaguideforclients–ProvideatoolforinspectionsDevelopment?RecentFDA/EMAguidancedocuments?BREL/GlobioxQuality,RegulatoryAffairs,Operations,andCommercialOperationsExperience?IndustryQuality/RegulatoryAffairsth
3、oughtleadersBasicConcepts?Definestherecommendedregulatoryleveloftesting(GLP/GCP/GMP/CLIA)foraproductappropriatetotheintendeduseofthedatagenerated.?Maintainflexibilitybetweendevelopmentandclinicaltrialmaterials.?FulfillFDA/EMAexpectationsconcerningdrugtestingpositiontoregulations.SomeReferences?21
4、CFRPart210+211,“CurrentGoodManufacturingPracticesinManufacturing,Processing,Packing,orHoldingofDrugsandFinishedPharmaceuticals”.?21CFRPart58,“GoodLaboratoryPracticeforNon-ClinicalLaboratoriesStudies”.?ICHQ9,“QualityRiskManagement”.?EUGuidetoGMP.?EuropeanClinicalTrialsDirective2001/20/EC.?UKMRHAGL
5、PRegulations.?ICHE6,“GoodClinicalPractice”.?ClinicalLaboratoryImprovementAmendments(Title42-PublicHealth,Part493,“LaboratoryRequirements).BasicPrinciplesofGLPforLabs1.InordertohaveGLP,youmusthaveaTestArticleandaTestSystem.2.GLPisNOTrelevanttoallregulatedlaboratorytests.3.GLPisonlyrelevanttonon-cl
6、inicaltesting.4.AGLPstudycanonlyhaveONEStudyDirector.BasicPrinciplesofGMPforLabs1.GMPappliestosomelaboratorytesting.2.IfalaboratorytestisdonetosupportmanufacturingofadrugproductitshouldbeincompliancewithGMP.BasicPrinciplesofGCPforLabs1.FDAGCPsdonotspecificallyaddresslabtesting2.ICHE6(GCP)definesl
7、abdataassourcedataforclinicaltrials3.FDAdoeshaveGuidelinesandregulationsconcerningElectronicdata.4.USusesCLIAcertification.GLP,GMP,orGCP??So,howdoweaslaboratoriansknowwhichRegulationtofollow?Definitions?GLP=CurrentGood
