GMP项目验证管理和质量管理课件

单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,*,Engineering Validation Management for Pharmaceutical Project,制药工程项目验证管理,徐文勤,Engineering Validation Managem,Index目录,Validation Mode 常见的验证模式,Validation Cooperation 验证各相关方的协作,Key Validation Activities 各阶段的主要验证活动,Index目录Validation Mode 常见的验证模,PQ,性能确认,PQ Test Plan,测试计划,URS,用户需求,OQ Test Plan,测试计划,OQ,运行确认,IQ,安装确认,IQ Test Plan,测试计划,Implement,执行,Detail Design,详细设计,Function Design,功能设计,Validation Mode-ISPE“V”Mode,常见的验证模式,-ISPE “V”,型确认模式,PQPQ Test Plan测试计划URS OQ Test,Validation Mode-ASTM E2500 Mode常见的验证模式-ASTM E2500 模式,用户需求,需求文件,需求,鉴别关键系统,测试,完工报告,影响因素评估,调试,IOQ,项目调试计划完工,IOQ,报告,确认测试,确认矩阵,设计复核,系统接受,报告放行,设计基础,仅注重产品,/,工艺,/,法规,/,项目质量战略要求,用户和其他要求的工程文件（如,EHS),各系统应有单独完工报告,测试是单一的,GEP,活动,包括调试，,SAT/FAT/IOQ,确认质量战略：基于需求文件的科学,/,风险导向流程,及设计复核,Validation Mode-ASTM E2500 Mo,Validation Mode-ASTM E2500 Mode常见的验证模式-ASTM E2500 模式,URS,Requirement Document,Requirements,Identification of Critical Aspects,Testing,Close-out Reports,Impact Assessment,Commissioning,IOQ,PCQP,Close-out,IOQ,Report,Verification Testing,VQS Matrix&Design Review,System Acceptance&release report,Design Basis,Focused on product/process and regulatory/PQS requirements only,Engineering Document for user and other requirements(i.e.EHS),Single close-out report for system,Testing is a single GEP activity-covering Commissioning,SAT/FAT/IOQ,Verification Quality Strategy:Science/Risk based approach based on requirement document and design review,Validation Mode-ASTM E2500 Mo,Validation Cooperation验证各相关方的协作,Owners Responsibilities 业主方的工作重点,Build Validation management system based on GMP quality system 建立基于GMP质量管理体系框架的验证管理体系,Project flexibility study and issue URS 评估项目的可行性并出具用户需求文件,Impact Assessment,include process and system 影响因素评估,包括工艺及系统,Prepare Validation Master Plan(VMP)验证主计划的制定,Involve in qualification activities,from DQ to OQ 从设计确认到运行确认的全过程参与,PQ activities 性能确认活动,Supplemented Validation Activities,such as PV,CV,CSV 后续的验证活动，如工艺验证、清洁验证、计算机验证,Validation Cooperation验证各相关方的,Validation Cooperation验证各相关方的协作,Contractors Responsibilities 项目总承包方的工作重点,Build Validation management system based on Project QMS 建立基于项目质量管理体系的验证管理体系,Prepare Specification based on owners URS 根据业主的用户需求 准备规格说明书,Impact Assessment,include process and system 影响因素评估,包括工艺及系统,Prepare Project Qualification Master Plan align with owners VMP 根据验证主计划（VMP）准备项目确认主计划（PQMP）,Vendor evaluation(validation execution capability)供应商评估（验证活动的执行能力）,DQ for Critical systems and process equipments 重要设施及重要工艺设备的设计确认（DQ）,Risk Analysis 风险分析,IOQ for Critical systems and process equipments 重要设施及重要工艺设备的安装、运行确认（IOQ）,FAT/SAT/Commissioning,Validation Cooperation验证各相关方的,Validation Cooperation验证各相关方的协作,System/equipment vendors responsibilities 设备/系统供应商的工作重点,Prepare and execute FAT/SAT/Commissioning Plans 完善出厂接受测试、现场接受测试、调试计划并执行,Participate in IOQ activities and prepare document 参与安装运行确认活动，并准备相关的文档,Prepare draft operational procedures for equipment and system 起草设备/系统相关操作规程草案,Support PQ activities 支持性能确认活动,Validation Cooperation验证各相关方的,Validation Cooperation验证各相关方的协作,独立测试机构及咨询机构,提供具有权威性的测试计划及测试数据,支持PQ,支持工艺自控系统的确认,提供各类后续的验证支持，如PV、CV、CSV,Validation Cooperation验证各相关方的,Key Validation Activities_ CD Phase各阶段的主要验证活动_概念设计阶段,GMP设计审核,对概念设计阶段的提交文件进行符合性审核，由于此阶段信息的粗略性，审核主要包括以下内容：,用户需求总纲性描述文件,工厂整体布局,工艺流程图及工艺总体描述文件,自控系统的概念性描述文件,Key Validation Activities_ CD,Key Validation Activities_ CD Phase各阶段的主要验证活动_概念设计阶段,Validation Strategy 验证策略,Main contents 主要内容,Regulatory requirement 法规依从性的要求,Training and qualification for design/execution team对设计/操作人员资质及培训的要求,Validation sequence 对验证序列的要求,Validation documentation 验证的文件化要求,Change Control and Deviation Management变更/偏差的处理,Key Validation Activities_ CD,Key Validation Activities_ BD Phase各阶段的主要验证活动_初步设计阶段,GMP设计审核,对初步设计阶段的提交文件进行符合性审核，审核主要包括以下内容：,用户需求(URS),各类设计规格描述(DS)及功能描述（FDS),管线仪表图,洁净分区图,Key Validation Activities_ BD,Key Validation Activities_ BD Phase各阶段的主要验证活动_初步设计阶段,Impact Assessment 影响因素评估,System Impact Assessment 系统影响因素,Process impact Assessment 工艺影响因素,Key Validation Activities_ BD,Key Validation Activities_ BD Phase各阶段的主要验证活动_初步设计阶段,Validation Master Plan&Master Qualification Plan验证主计划及项目确认主计划,VMP focus on 主要讨论以下几个方面的内容：,Define Validation Scope based on impact assessment 验证范围的确定：基于影响因素评估结论,Define Responsibility 验证各方职责的划分,Define Validation Strategy:detailed from CD phase 验证策略的确定：CD阶段的验证策略的深化,Validation Sequence and rough schedule 验证的顺序及大致的进度,Description of key process and Technocal 关键工艺及技术的简要描述,Description of key validation activities 各项验证活动的大致描述,MQP focus on qualification activities only 项目确认主计划描述确认活动中各方的活动,Key Validation Activities_ BD,Key Validation Activities_ BD Phase各阶段的主要验证活动_初步设计阶段,质量验证活动,各类验证相关规程的建立，如偏差/变更管理、培训规程、文件规范,相关指导原则的导入：如设备/设施确认原则、自控确认原则、HVAC确认原则,供应商的预确认,Key Validation Activities_ BD,Key Validation Activities_ DD Phase各阶段的主要验证活动_详细设计阶段,GMP Design Review设计审核,Compliance Review on Detail Design Deliverables,mainly includes:对详细设计阶段的提交文件进行符合性审核，审核主要包括以