与制药工程项目全过程相整合的调试与确认服务卢浩荣Agenda议程2012ISPECHINAANNUALCONFERENCE2012ISPECHINAANNUALCONFERENCE2012ISPECHINAANNUALCONFERENCE2012ISPECHINAANNUALCONFERENCE2012ISPECHINAANNUALCONFERENCE2012ISPECHINAANNUALCONFERENCE2012ISPECHINAANNUALCONFERENCE2012ISPECHINAANNUALCONFERENCE2012ISPECHINAANNUALCONFERENCE2012ISPECHINAANNUALCONFERENCEPre-DesignRiskManagement风险管理DesignReview设计审核ChangeManagement变更管理2012ISPECHINAANNUALCONFERENCE2012ISPECHINAANNUALCONFERENCE2012ISPECHINAANNUALCONFERENCE2012ISPECHINAANNUALCONFERENCE2012ISPECHINAANNUALCONFERENCE2012ISPECHINAANNUALCONFERENCE2012ISPECHINAANNUALCONFERENCE2012ISPECHINAANNUALCONFERENCE2012ISPECHINAANNUALCONFERENCE2012ISPECHINAANNUALCONFERENCE2012ISPECHINAANNUALCONFERENCE2012ISPECHINAANNUALCONFERENCE2012ISPECHINAANNUALCONFERENCEImplementationFlowofPharmaceuticalProject制药工业项目实施流程Workflow—abriefcasestudy(WFIsystem)工作流程–简略的案例分析(注射用水系统）Specifythefinalusers,capacity,standards，etc.tobefollowedforWFI.systeminF-URS在设施URS中明确注射用水系统的终端用户、供应能力以及遵循的标准等。ImplementGAfortherenovatedsystems.对改造的系统进行偏差分析。DeveloptheschematicdesignofWFIsystem(e.g.MB,PFD，mainequipmentlist)intheBODofthefacility（designconsultant).在设施的设计基础中进行注射用水系统的方案设计（物料平衡、工艺流程图,主要设备表等）(设计咨询方）。Workflow—abriefcasestudy(WFIsystem)（cont.)工作流程–简略的案例分析(注射用水系统）(续）ImplementtheIAoftheWFIsystemaccordingtothecriteria.按照判据进行注射用水的影响评估。SpecifythelevelofC&Qs(includingCSV)andtherationaleofthesysteminVMP.在验证总计划中阐明调试确认(包括计算机系统验证）的程度及原因.DeveloptheURSofthesystem(includingtheC&Qrequirement),VPbasedonRA.在风险分析的基础上编制系统的URS及验证计划.Workflow—abriefcasestudy(WFIsystem)（cont.)工作流程–简略的案例分析(注射用水系统）(续）DevelopFS、DSfortheWFIsystem(BD,DD—designconsultantorcontractor).编制注射用水系统的功能说明、设计说明（基础设计、详细设计—设计方或承包商）。DeveloptheCommissioning(e.g.FAT/SAT)planandDQ、IQ、OQprotocolsfortheWFIsystemwithaC&Qintegratedapproach.以调试与确认相整合的方式编制调试（如FAT/SAT）计划和DQ、IQ、OQ方案。ImplementtheDQoftheWFIsystemwithstructuralreviewapproachandFEMA(basedonC-IA)采用结构化审核方式和建立在部件影响评估基础上的潜在故障形式和影响分析（设计FMEA)进行注射用水系统的设计确认。Workflow—abriefcasestudy(WFIsys