PDA-Technical-Report-No.-65-(TR-65)--Technology-Tr

BethesdaTowers4350EastWestHighwaySuite200Bethesda,MD20814USATel:1(301)656-5900Fax:[phone]E-mail:[e-mail]:(TeamLeader)DerekBlaettler,F.Hoffman-LaRoche,Ltd.AmnonElyath,GenzymeCorporationStephanKrause,Ph.D.,MedImmuneAndreaMorelli,KedrionBiopharmaChittoorNarahari,GlaxoSmithKlineJamieRogers,BiogenIdecVictorSanchez,Pharma-BioServS.L.MelissaSeymour,BiogenIdecYiXie,Ph.D.,EliLillyandCompanyWaylandRushing,Ph.D.,AnalyticalBio-ChemistryLaboratories,Inc.DaveWohlpart,Ph.D.,Merck&Co.Thecontentandviewsexpressedinthistechnicalreportaretheresultofaconsensusachievedbytheauthoringtaskforceandarenotnecessarilyviewsoftheorganizationstheyrepresent.:978-0-939459-68-1©2014ParenteralDrugAssociation,Inc.Allrightsreserved.BethesdaTowers4350EastWestHighwaySuite200Bethesda,MD20814USATel:1(301)656-5900Fax:[phone]E-mail:[e-mail]:(PCMOSM)PDAlaunchedtheprojectactivitiesrelatedtothePCMOprograminDecember2008tohelpimple-mentthescientificapplicationoftheICHQ8,Q9andQ10series.ThePDABoardofDirectorsap-provedthisprogramincooperationwiththeRegulatoryAffairsandQualityAdvisoryBoard,andtheBiotechnologyAdvisoryBoardandScienceAdvisoryBoardofPDA.Althoughthereareanumberofacceptablepathwaystoaddressthisconcept,thePCMOprogramfol-lowsandcoversthedrugproductlifecycle,employingthestrategicthemeofprocessrobustnesswith-intheframeworkofthemanufacturingoperations.ThisprojectfocusesonPharmaceuticalQualitySystemsasanenablerofQualityRiskManagementandKnowledgeManagement.UsingtheParenteralDrugAssociation’s(PDA)membershipexpertise,thegoaloftheParadigmChangeinManufacturingOperationsProjectistodrivetheestablishmentof‘bestpractice’docu-mentsand/ortrainingeventsinordertoassistpharmaceuticalmanufacturersofInvestigationalMedicinalProducts(IMPs)andcommercialproductsinimplementingtheICHguidelinesonPhar-maceuticalDevelopment(ICHQ8,Q11),QualityRiskManagement(ICHQ9)andPharmaceuticalQualitySystems(ICHQ10).ThePCMOprogramfacilitatescommunicationamongtheexpertsfromindustry,universityandregula-torsaswellasexpertsfromtherespectiveICHExpertWorkingGroupsandImplementationWorkingGroup.PCMOtaskforcemembersalsocontributetoPDAconferencesandworkshopsonthesubject.PCMOfollowstheproductlifecycleconceptandhasthefollowingstrategicintent:• Enable an innovative environment for continual improvement of products and systems • Integrate science and technology into manufacturing practice • Enhance manufacturing process robustness, risk based decision making and knowledge manage-ment• Foster communication among industry and regulatory authorities ProductDiscontinuationCommercialManufacturingTechnologyTransferPharmaceuticalDevelopmentTheProductLifeCycleFormoreinformation,includingthePCMODossier,andtogetinvolved,goto:Planning..........................................124.1.1ProjectRationale.....................................124.1.2ProjectScope.........................................124.1.2.1TechnologytobeTransferred.............134.1.2.2Scale-upofProductionLevel.............144.1.2.3ControlPhilosophy....................