2014PDA_(TR_65)Technology_Transfer技术转移

本文档仅用于学术交流，严禁用于其它用途11TechnicalReportNo.65TechnologyTransfer技术转移PDA2014翻译人员名单序号章节页码认领人11.0-2.01-233435244423.03-11glm102434.0-4.1712-20一沙一叶44.2-4.521-30yan13025531-41开羽66.0-6.2.442-47lumang76.347-56本文档仅用于学术交流，严禁用于其它用途2TableofContents目录1.0Introduction简介2.0Glossaryofterms术语3.0TechnologyTransferProject技术转移项目4.0TechnologyTransferProcess技术转移过程5.0ApplicationofQualityRiskManagementtoTechnologyTransfer技术转移中质量风险管理的应用6.0CaseStudies案例分析7.0References参考文献8.0AdditionalReading其它阅读FiguresandTablesIndex表格及索引Figure3.4-1TypicalFunctionswithinaTTPTable3.4-1TechnologhyTransferOrganizationalComponentsTable3.4.2.1-1ResponsibilitiesoftheSUandRUFigure3.4.5-1CommonFlowofInformationandCommunicationWithinaTechnologyTransferTeamandProjectTable5.4-1QRMApproachesatEachStageGateofTTPTable6.1-1SuggestedAMTResponsibilityMatrixTable6.1.2-1GeneralAMTDesignParametersandConsiderationsTable6.1.3-1ExamplesofMethodTypesandAMTPerformanceCharacteristicsTable6.1.4-1TypicalAMTProtocolSectionsFigure6.2.3-1Process/ProductComparabilityFrameworkFigure6.3.1-1OverallProcessMappingTable6.3.1-1ExampleofVariableDefinitionsTable6.3.1-2ExampleofQualityAttributesDefinitionTable6.3.1-3SeverityDefinitionandRatingTable6.3.1-4OccuranceDefinitionandRatingTable6.3.1-5DetectionDefinitionandRatingTable6.3.1-6RiskAnalysis（蒲公英论坛翻译群作品）本文档仅用于学术交流，严禁用于其它用途331.0introduction简介Pharmaceuticaltechnologytransferconsistsofplannedandcontrolledactionsthatarebasedonwelldefinedacceptancecriteriatoconveyamanufacturingprocess,analyticalmethod,packagingcomponent,oranyothersteporprocessalongthepharmaceuticaldruglifecyclefromanoriginatorsite,knownasasendingunit(SU),toanewsite,thereceivingunit(RU).制药技术转移包含一些有计划的和受控的活动，这些活动根据规定好的可接受标准，从转出方（SU）传递生产工艺、分析方法、包装材料、或者其他任何与药品生命周期有关的步骤或者工艺到接收方（RU）。1.1purpose/目的Thepurposeofthistechnicalreportistoprovideguidanceandbestpracticesforconductingtechnologytransferactivitiesinthepharmaceuticalindustry.这篇技术报告的目的是为制药工业进行药品技术转移活动提供指南和最佳实践。1.2scope/范围Thereportprovidesanoverviewoftheknowledgeandskillsusedduringasuccessfultechnologytransferproject(TTP)alongwithreferencestoconsult,ifnecessary.Thereportincludespracticalexamplesoftechnologytransferactivities.Ratherthandiscussaparticulartechnologytransfertopic,thisreportaimstoprovideaguidetosafeTTPmanagement.本报告提供了一个成功的技术转移项目（TTP）使用的知识和技巧的概述，以及必要时可用的参考。本报告包括技术转移实例。不仅仅是讨论一个既定的技术转移主题，本报告也着眼于为保证的TTP管理提供指南。Thisreportdoesnotaddresslogisticsandbridgingstocks,whicharecomprehensivelydiscussedinTechnicalReportNo.52:GuidanceforGoodDistributionPractices(GDPs)(1).本报告不讨论物流和库存衔接，这个方面在第52号技术报告《良好分销实践指南GDPs》中有广泛讨论。Thetechnologytransferorganizationalelementsoutlinedinthistechnicalreportmightnotbeappropriateforallcompanies.Establishedpracticesortheavailabilityofpersonnelwilldictatehowfirmsconducttechnologytransferactivities.这篇技术报告中列出的技术转移组织机构可能不适用于所有公司。各公司己有的实践和人员将决定公司如何管理技术转移活动。本文档仅用于学术交流，严禁用于其它用途42.0GlossaryofTerms术语FailureModeEffectsAnalysis(FMEA)/失败模式影响分析（FMEA）Atoolforanalyzingprocessesorsystemstoevaluatealloperatingstepsinordertoidentifyandassesstheriskassociatedwithanypotentialfailures(2).用于分析过程或系统的一个工具，通过评估所有操作步骤来识别和评估任何潜在导致失败的风险。PlanningBillofMaterials(BOM)/物料计划清单（BOM）Acompletelistoftherawmaterial(chemicals,media,powders,resin,etc.)andconsumables/components(filters,bags,tubing,containers,etc.)thatarerequiredtomanufacturetheproduct.一个生产产品所需的原料（化工品、媒介、粉末、树脂等）和耗材/组分（过滤器、袋子、管道、容器等）的完整清单。ProcessFlowDiagram(PFD)/工艺流程图（PFD）Adocument,typicallypreparedbyR&D,thatdescribestheintendedmanufacturingprocess.ThePFDincludesallrelevantinformationfortheoperationofthemanufacturingprocess,organizedbyunitoperation.ThePFDservesasthesourcedocumentfortheinitialdevelopmentofthemasterproductionrecordsandislockeddownoncedevelopmenthasdeterminedthattheprocesscanbecontrolled.一个描述计划使用的生产工艺的文件，通常由研发编写。PFD通过单元操作来组织，包含了所有生产工艺操作相关的信息。PFD是初期起草主批生产记录的源文件，并且在确定工艺可控时，该文件将被锁定。ReceivingUnit(RU)/转入方（RU）Termfortheinternalorexternalrecipientorsitewherethetechnologyisbeingtransferredto.定义为内部或者外部接收技术的接收方或接收地。SendingUnit(SU)/转出方（SU）Termfortheinternalorexternalsourceororiginatorsiteofthetechnologytobetransferred.定义为内部或者外部转出技术的来源或始发地。WorkBreakdownStructure(WBS)/工作分解结构（WBS）Ahierarchicalandincrementaldecompositionofaprojectintophases,deliverables,andworkpackages;commonlyatreestructurethatshowsasubdivisionofeffortrequiredtoachieveanobjective.将一个项目按层级、按过程分解成阶段、可交付成果和工作包，通常是一个树状的结构展示了实现目标需要的各级努力。MaterialSafetyDataSheet(MSDS)/物料安全数据表（MSDS）Informationprovidedwithchemicalsandothermaterialsintendedtoprovideworkersandemergencypersonnelwithproceduresforhandlingorworkingwiththatsubstanceinasafemanner.提供给化工品或其他物料的信息，用于指导工人和应急人员安全操作或使用该物质。蒲公英论坛翻译群作品本文档仅用于学术交流，严禁用于其它用途553.0TechnologyTransferProject技术转移项目Atechnologytransferprocedureismoreofaprojectthanaprocess,asdescribedbytheProjectManagementBodyofKnowledge(PMBOK)Guide.Theguidedescribesaprojectasadefinedsumofnon-repetitiveactivitiesthataredesignedtoachieveagoal,areperformedinadefinedtimerange,employdefinedresources,andaremanagedbyateam.Aprocess,bycontrast,isthestepsagivenprojectfollows(3).根据项目管理知识指南(PMBOK)的描述，技术转移程序是一个项目而不仅仅是一个过程。该指南描述的项目是一个各种