与制药工程项目全过程相整合的调试与确认服务卢浩荣.pptxVIP

CHINA ANNUAL CONFERENCE 16th – 17th April 2012, Beijing;Agenda议程;2012 ISPE CHINA ANNUAL CONFERENCE;2012 ISPE CHINA ANNUAL CONFERENCE;2012 ISPE CHINA ANNUAL CONFERENCE;2012 ISPE CHINA ANNUAL CONFERENCE;2012 ISPE CHINA ANNUAL CONFERENCE;2012 ISPE CHINA ANNUAL CONFERENCE;2012 ISPE CHINA ANNUAL CONFERENCE;2012 ISPE CHINA ANNUAL CONFERENCE;2012 ISPE CHINA ANNUAL CONFERENCE;2012 ISPE CHINA ANNUAL CONFERENCE;;Pre-Design;Risk Management 风险管理 Design Review 设计审核 Change Management 变更管理;;2012 ISPE CHINA ANNUAL CONFERENCE;2012 ISPE CHINA ANNUAL CONFERENCE;2012 ISPE CHINA ANNUAL CONFERENCE;2012 ISPE CHINA ANNUAL CONFERENCE;2012 ISPE CHINA ANNUAL CONFERENCE;2012 ISPE CHINA ANNUAL CONFERENCE;2012 ISPE CHINA ANNUAL CONFERENCE;2012 ISPE CHINA ANNUAL CONFERENCE;2012 ISPE CHINA ANNUAL CONFERENCE;2012 ISPE CHINA ANNUAL CONFERENCE;2012 ISPE CHINA ANNUAL CONFERENCE;2012 ISPE CHINA ANNUAL CONFERENCE;2012 ISPE CHINA ANNUAL CONFERENCE;;;;;Implementation Flow of Pharmaceutical Project制药工业项目实施流程;;Workflow—a brief case study (WFI system) 工作流程 –简略的案例分析(注射用水系统） Specify the final users, capacity, standards，etc. to be followed for WFI. system in F-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。 Implement GA for the renovated systems. 对改造的系统进行偏差分析。 Develop the schematic design of WFI system (e.g. MB, PFD，main equipment list) in the BOD of the facility （design consultant). 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—a brief case study (WFI system)（cont.) 工作流程 –简略的案例分析(注射用水系统）(续） Implement the IA of the WFI system according to the criteria. 按照判据进行注射用水的影响评估 。 Specify the level of CQs (including CSV) and the rationale of the system in VMP. 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. Develop the URS of the system (including the CQ requirement), VP based on RA. 在风险分析的基础上编制系统的URS及验证计划. ;Workflow—a brief case study (WFI system)（cont.) 工作流程 –简略的案例分析(注射用水系统）(续） Develop FS、DS for the WFI system(BD, DD—design consultant or contractor). 编制注射用水系统的功能说