PDATR29(2012)清洁验证中英对照版

BethesdaTowers4350EastWestHighwaySuite200Bethesda,MD20814USATel:1(301)656-5900Fax:[phone]E-mail:[e-mail]:(Revised2012)PointstoConsiderforCleaningValidationParadigmChangeinManufacturingOperationsSMLicensedtoJiang,Binjun/PharmaceuticalEngineering:CopyingandDistributionProhibited.PDATaskForceonTechnicalReportNo.29(Revised2012):PointstoConsiderforCleaningValidationAuthorsDestinA.LeBlanc,CleaningValidationTechnologies(Chair)GretchenAllison,PfizerJenniferL.Carlson,GenentechKoshyGeorge,ConsultantIgorGorsky,ConcordiaValSourceIrwinS.Hirsh,NovoNordiskASJamieOsborne,Siegfried(USA),Inc.GregRandall,BaxterBiosciencePierre-MichelRiss,EliLillyGeorgeVerghese,STERISCorporationJennWalsh,Bristol-MyersSquibbVivienneYankah,Sanofi-Pasteur,Ltd.ThecontentandviewsexpressedinthisTechnicalReportaretheresultofaconsensusachievedbytheauthorizingTaskForceandarenotnecessarilyviewsoftheorganizationstheyrepresent.LicensedtoJiang,Binjun/PharmaceuticalEngineering:CopyingandDistributionProhibited.PointstoConsiderforCleaningValidationTechnicalReportNo.29(Revised2012)ISBN:978-0-939459-48-3©2012ParenteralDrugAssociation,Inc.Allrightsreserved.BethesdaTowers4350EastWestHighwaySuite200Bethesda,MD20814USATel:1(301)656-5900Fax:[phone]E-mail:[e-mail]::CopyingandDistributionProhibited.ParadigmChangeinManufacturingOperations(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:CopyingandDistributionProhibited.1.0Introduction.........................................................11.1Purpose/Scope................................................12.0GlossaryofTerms...............................................32.1DefinitionofAcronyms....................................53.0CleaningProcessDesignandDevelopment.......73.1CleaningProcessDesign.................................73.2CleaningProcessOverview.............................83.2.1Physical-chemicalAspects.................93.3DesignConsiderations...................................103.3.1LocationofCleaning..........................103.3.1.1In-PlaceCleaning..........................103.3.1.1.1Clean-in-Place(CIP)Systems.......103.3.1.1.2SolventRefluxCleaning................113.3.1.1.3PlaceboBatchesasaCleaningMethod..........................113.3.1.2Out-of-PlaceCleaning...................113.3.1.2.1Clean-Out-of-PlaceSystems.........123.3.2Automatedvs.ManualSystems.......123.3.2.1ManualProcesses........................123.3.2.2Semi-AutomatedProcesses.........123.3.2.3AutomatedProcesses..................133.3.3SoilEvaluationandCategorization.....133.3.3.1SoilCategories.............................133.3.3.2SoilRemoval.................................133.3.4EquipmentConsiderations.................143.3.4.1Dedicated–NondedicatedManufacturingEquipment............143.3.4.2NonproductContact–ProductContactSurfaces..........................153.3.4.3Low-RiskSites–High-RiskSites.153.3.4.4MaterialsofConstruction.............153.3.5OperationalConsiderations................153.3.6CleaningAgentSelection..................163.3.7ProductConsiderations......................163.3