设备验证1889724431

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1、设备验证设备验证2008年11月2023/4/241Validation验证“Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.建立一个文件化的证据,以提供一个高水准的保证体系,确保生产出的产品始终符合预定的标准和质量要求。FDA Guideline

2、s on General Principles of Process Validation,May 1987.Documents文件2023/4/242Operational运行确认 QualificationInstallation 安装确认QualificationDesign Qualification设计确认Sequence of documents文件建立次序SpecificationQualification标准确认-URS用户需求-SpecificationsSystem 设计基础文件设计&安装-Mechanical机械Air unit空调Electrical电设计&安装Hard

3、ware硬件Software软件IQ安装确认-ACSHardware硬件Software软件IQ安装确认-Mechanical机械Air unit空调Electrical电OQ运行确认-ACSHardware硬件Software软件OQ运行确认-Mechanical机械Air unit空调Electrical电PerformanceQualification性能确认-SystemSystem Owner系统使用者Engineering C.工程部ACS C计算机工程师.Mech.C.机械工程师ACS C./System Owner 计算机工程师/系统使用者Mechanical C./Syste

4、m Owner机械工程师/系统使用者System Owner系统使用者2023/4/243V Model Life Cycle2023/4/244URS-system level用户需求Specifications标准URS用户需求project level项目层面参数一览表System list系统清单Block diagram设计结构图纸概括的系统描述PFD流程图Criticality analysis重要项分析Master Validation Plan验证主计划Traceability matrix矩阵图Good for design用于设计2023/4/245Design-Basic

5、 documents 基础设计文件Detailed system description详细系统描述PIDGeneral system description概括的系统描述PFD流程图Room data sheets Parameters参数一览表Traceability matrix矩阵图Instrument list仪表清单Equipment list设备清单Parameter list参数清单Alarm list报警项目清单Good for construction用于制造Traceability matrix矩阵图2023/4/246Design&Installation-ACS/So

6、ftware设计及安装软件Detailed system description详细系统描述Parameter list参数清单Alarm list报警项目清单PIDInstrument list仪表清单Equipment list设备清单Traceability matrix矩阵图Software design concept软件概念设计Test plan测试计划Test documents FAT设备生产厂测试文件Program review report回顾报告Ready for FATTraceability matrix矩阵图2023/4/247Ready for FAT进入设备生产

7、厂测试阶段Design&Installation-ACS/Hardware设计及安装硬件Detailed system description详细的系统描述Parameter list参数清单Alarm list报警清单PIDInstrument list仪表清单Equipment list设备清单Traceability matrix矩阵图Hardware design concept硬件概念设计I/O list I/O清单Address list 地址清单Data sheets Instruments仪表一览表PLC configuration PLC配置Electrical drawin

8、gs电气图Traceability matrix矩阵图2023/4/248Design&Installation Mechanical设计&安装机械部分Detailed system description详细的系统描述Parameter list参数清单Alarm list报警清单PIDInstrument list仪表清单Equipment list设备清单Traceability matrix矩阵图Air ducting layout空调管路图Electrical layout电气图Equipment layout设备图Piping layout管道图Data sheets Equipm

9、ent设备一览表Ready for SAT进入SATReady for FAT进入FAT2023/4/249Testing-FAT software测试FAT软件部分Traceability matrix矩阵图FAT测试文件FAT procedures程序FAT protocols方案FactoryAcceptanceTest设备生产厂测试Software FAT report软件部分测试报告Software软件2023/4/2410Testing-FAT hardware测试FAT硬件部分Traceability matrix矩阵图Test documents FAT测试文件FAT proc

10、edures程序FAT protocols方案FactoryAcceptanceTest设备生产厂测试hardware FAT report硬件的FAT报告Hardware硬件Calibration certificates校验证书2023/4/2411Testing-FAT Equipment测试FAT 设备部分Traceability matrix矩阵图Test documents FAT测试文件FAT procedures程序FAT protocols方案FactoryAcceptanceTest设备生产厂测试Equipment FAT report设备的FAT报告Equipment设备

11、Certificates合格证书2023/4/2412Field installation verification 现场安装确认Traceability matrix矩阵图Design documents设计文件IO test protocolIO测试方案Tightness test protocols严密的测试方案Field installation verification Report现场安装确认报告System系统FieldInstallationVerification现场安装确认2023/4/2413Approval 1批准Software FAT report软件的FAT报告H

12、ardware FAT report硬件的FAT报告Equipment FAT report设备FAT报告Field installation verification report现场安装报告Approved批准Ready for SAT进入SAT2023/4/2414Testing-SAT software测试SAT 软件Traceability matrix矩阵图Test documents SATSAT测试文件SAT procedures程序SAT protocols方案SiteAcceptanceTest工厂测试Software SAT report软件SAT报告Software软件

13、2023/4/2415Testing-SAT equipment测试SAT 设备部分Traceability matrix矩阵图Test documents SATSAT测试文件SAT procedures程序SAT protocols方案SiteAcceptanceTest工厂测试Equipment SAT report设备SAT报告Equipment设备Certificates合格证书2023/4/2416Approval 2Software SAT report软件SAT报告Equipment SAT report设备SAT报告Ready for Performance testing进

14、入性能测试Approved 批准2023/4/2417Systems1 System=1 PID Example如:1 air handling unit一个空调单元1 clean steam generator一个清洁蒸汽发生器3 holding tanks三个储罐A system is a composition of components that logically cohere in order to fulfil a particular functionality一个系统是由多个单元组成的复合体，各单元组合在一起而完成特定的功能2023/4/2418Traceability追溯性

15、Project documents must be traceable to requirements项目文件必须有追溯性 Design documents must be traceable to URS 设计文件对应于URS Testing must be traceable to design specification and URS测试对应于设计标准和URSURSproject levelURS项目层面URSsystem levelURS系统层面DesignDocuments设计文件Tests测试Use of a traceability matrix is the recommen

16、ded method推荐用 追溯性的矩阵图2023/4/2419Criticality关键Criticality Analysis is essential to good project重要性分析是一个好项目成功的关键 intended to focus effort on most critical areas for GXP最重要的是GXP的符合性GLPGCPGMPURSCriticality Analysis重要性分析URS update更新用户需求SOP程序Detailed system description详细的系统描述Compares GXPwith URS paragraphs逐段比对URS与GXP符合性Defines actions forProject and Owne项目组和用户确定必要的行动rHighlights SOP and DSD controls简述SOP与系统描述中重点2023/4/2420演讲完毕，谢谢观看！