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1、TechnicalReportNo.60ProcessValidation:ALifecycleApproachParadigmChangeinSMManufacturingOperationsBethesdaTowers4350EastWestHighwaySuite200Bethesda,MD20814USATel:1(301)656-5900Fax:1(301)986-0296E-mail:info@pda.orgWebsite:www.pda.orgPDATaskForceonTechnicalReportNo.60:ProcessValidatio
2、n:ALifecycleApproachAuthorsScottBozzone,Ph.D.,Chair,Pfizer,Inc.RajJani,BaxterHealthcareCorporationHaroldS.Baseman,Co-Chair,Valsource,LLCPeterF.Levy,PLConsulting,LLCVincentAnicetti,ParenteralDrugAssociation,KeckMichaelLong,PhDConcordiaValsource,LLCGraduateInstituteJohnMcShane,Roche-
3、Genentech,Inc.JohnA.Bennan,Ph.D.,ComplianceNet,Inc.VictorG.Maqueda,Sr.,ConsultantMichaelN.Blackton,ImcloneSystems,Inc.JoséLuisOrtega,PharmaMarS.A.SociedadUnipersonalVijayChiruvolu,Ph.D.,MBA,Amgen,Inc.ElizabethPlaza,Pharma-BioServ,Inc.RebeccaA.Devine,Ph.D.,ConsultanttotheBio-pharmac
4、euticalIndustryPraveenPrasanna,Ph.D.,ShireHumanGeneticTherapies,Inc.StephenDuffy,Covidien,LLCDavidReifsnyder,Roche-Genentech,Inc.PannaL.Dutta,Ph.D.,TheMedicinesCompanyMarkusSchneider,Ph.D.,NovartisPharmaAGKurtisEpp,BioTechLogic,Inc.IolandaTeodor,BaxterHealthcareCorporationIgorGorsk
5、y,ShirePharmaceuticals,Inc.NorbertHentschel,BoehringerIngelheimPharmaMarkVarney,AbbottLaboratoriesGmbH&Co.,KGAlpaslanYaman,Ph.D.,Biotech,PharmaandDevicePedroHernandez,Ph.D.,PHPD,LLCConsulting,LLCIrwinHirsh,NovoNordiskA/SWendyZwolenski-Lambert,AbbottLaboratoriesThistechnicalreportwa
6、sdevelopedaspartofPDA’sParadigmChangeinManufacturingOperations(PCMO)project.ThecontentandviewsexpressedinthisTechnicalReportaretheresultofaconsensusachievedbythemembersoftheauthorizingTaskForce,andarenotnecessarilytheviewsoftheorganizationstheyrepresent.ProcessValidation:ALifecycle
7、ApproachTechnicalReportNo.60ISBN:978-0-939459-51-3©2013ParenteralDrugAssociation,Inc.Allrightsreserved.BethesdaTowers4350EastWestHighwaySuite200Bethesda,MD20814USATel:1(301)656-5900Fax:1(301)986-0296E-mail:info@pda.orgWebsite:www.pda.orgSMParadigmChangeinManufacturingOperations(PCM
8、O)PDAlaunchedtheprojectact
