工程验证和相关文件清单

1、工程验证及相关文件目录验证主计划目录 （VMP）1INTRODUCTION序言2REFERENCES 参考2.1GMP Rules and guidelines GMP法规和指南2.2Design documents设计文件3FACILITY OVERVIEW 厂房概要3.1Production Areas 生产区3.2R&D and QC Laboratories 研发和QC 实验室3.3Warehouse 仓库4XXXX MANUFACTURING PROCESS DESCRIPTION XXX生产工艺描述5Areas Classification 区域分类5.1Cleanline

2、ss Area Classification 洁净区分类5.2HVAC Systems 空调系统5.2.1XXXX Production Areas XXXX生产区6Personnel and material Flow 人流和物流6.1Personnel flow 人流6.2Material Flow 物流7Pressure Lay Out 压力分布图8UTILITIES 公用设施8.1Process Utilities 工艺用公用设施8.1.1Purified Water 纯水8.1.2Process air 工艺用空气8.1.3Pure Nitrogen纯氮8.2TECHNICAL UT

3、ILITIES 技术用公用设施8.2.1POTABLE WATER (W) SYSTEM饮用水系统8.2.2HOT WATER FOR HVAC (HWS)空调用热水系统8.2.3HOT SANITARY WATER (HSWS)卫生型热水8.2.4MEDIUM AND LOW PRESSURE STEAM中压和低压蒸汽8.2.5COMPRESSED AIR压缩空气8.2.6CHILLED WATER冷冻水8.3SUPPORT SYSTEMS 配套系统8.3.1PROCESS SEWER工艺废水8.3.2EQUALISATION/NEUTRALISATION SYSTEM中和系统8.3.3GA

4、SEOUS EFFLUENTS HANDLING气体处理系统8.3.4FIRE WATER SYSTEM消防系统8.3.5FOAM SYSTEM消防泡沫系统8.3.6DRY CHEMICAL SYSTEM干粉系统8.3.7CARBON DIOXIDE SYSTEM二氧化炭系统8.3.8FIRE-FIGHTING SYSTEM SELECTION火灾报警系统9CRITICAL PROCESS STEPS and CRITICAL EQUIPMENT 关键的工艺步骤和关键设备10VALIDATION APPROACH 验证方法10.1GMP Review GMP审核10.2Design Quali

5、fication 设计确认10.3Factory Acceptance Test 工厂验收测试10.4Mechanical completion 机械性完工10.5Calibration 校准10.6Commissioning 调试10.7Site Acceptance Test 现场验收测试10.8Validation Turn over package (Vtop) 验证文件包10.9Installation Qualification 安装确认10.9.1IQ Acceptance Criteria可接受标准10.10Computer Installation Qualification

6、 计算机系统的安装确认10.10.1CIQ acceptance criteria 可接受标准10.11Operational Qualification 运行确认10.11.1OQ Acceptance Criteria运行确认的可接受标准10.12Computer Operational Qualification计算机运行确认10.12.1COQ acceptance criteria可接受标准10.13Performance Qualification (PQ) 性能确认10.13.1PQ Acceptance Criteria可接受标准10.14Process Validation

7、工艺验证10.14.1Process Validation 工艺验证10.14.2Process Validation Acceptance criteria 工艺验证可接受标准10.15Cleaning Validation 清洗验证10.15.1Cleaning Validation 清洗验证10.15.2Cleaning Validation Acceptance criteria 清洗验证的可接受标准10.16Specific acceptance criteria for Qualification 确认工作的特定的可接受标准10.16.1HVAC, LAF and Architec

8、ture Room Finishing空调系统、层流装置和房间的装饰10.16.2Purified Water Production, Storage and Distribution 纯化水生产、存储和分配系统10.16.3Compressed Air 压缩空气10.16.4Nitrogen 氮气10.16.5Scales 称量装置10.16.6XXX Melter and Filling solution Preparation TankXXX罐和内容物溶液配制罐10.16.7Raw material,XXXX and Filling solution Holding Tanks 原料、X

9、XXX和内容物溶液保存罐10.16.8XXXX Base turbo mixer XXXX着色器10.16.9XXX machine XX机10.16.10Tumble Dryer 转筒式干燥机10.16.11Drying Tunnel 干燥隧道10.16.12Sorting machine 拣丸机10.16.13XXXXs Washing machine (Future) 洗丸机10.16.14XXXX printing machine(Future) XXXX打字机10.16.15Optical inspection machine目检机10.16.16Blistering machine

10、铝塑包装机10.16.17Bottle Filling machine装瓶机10.16.18Capping machine 封盖机10.16.19Labeling machine贴标机10.16.20Boxing machines装盒机10.16.21Cartoning machine装箱机11COMMISSIONING & VALIDATION MATRIX调试和验证矩阵12COMMISSIONING & VALIDATION TIME SCHEDULE验证时间进度表13LIST OF SOP'S标准操作程序清单14QUALIFICATION/VALIDATION M

11、ETHODOLOGY验证方法14.1Protocol Generation方案的形成14.2Protocol Approval方案的批准14.3Protocol Execution方案的执行14.4Review of Execution & Raw Data执行和原始数据的审核14.5Final Summary Report Generation最终总结性报告的形成14.6Change Control变更控制15RESPONSIBILITY职责15.1General Manager技术总监15.2Quality Assurance/Control经理15.3Quality Contro

12、l质量控制15.4Project Manager项目经理15.5Production Manager 生产经理15.6Contractors 合同商16SUPPORT SERVICES支持性服务16.1Training培训16.2Preventive maintenance预防性维护保养16.3Calibration校准17RE-QUALIFICATION/VALIDATION SCHEDULE重新验证时间安排18LIST OF ATTACHMENTS 附件清单水系统验证报告文件清单 Water System设计确认DQ 1.目的Purpose2.职责 Responsibility3.设计参考

13、文件清单 Reference Document List4.设备描述 System Description 5.设计确认描述和可接受标准 Design Description & Acceptance Ctiteria5.1先决条件Prerequisites5.2设计文件确认Design Document Verification 5.3安全确认 Safety Verification 5.4系统温度的确认 Temperature Verification 5.5系统流速和生产能力的确认 Velocity & Capacity Verification 5.6仪表确认 Inst

14、rument Verification 5.7材料和物体表面的检查 Material & Surface fininshing Verification 5.8润滑剂的确认 Lubricant Verification 5.9排水能力的确认 Drainablity Verification 5.10系统设备、管道、联结件结构的确认 Main Compoment, Piping & Jointer Verification 5.11控制系统的确认Control System Verification 5.12系统安装焊接工作要求的确认 Welding Verification 5

15、.13系统清洗和钝化的确认Pickling and Passivation Verification 5.14系统在线灭菌能力的确认SIP Verification 6.人员的鉴别Personnel Identification 7.偏差报告Deviation Report8.注释 Comment 9.偏差清单Deviation List10.附件清单 Attachment List11.回顾和批准 Review & Approval 12.改造和更改控制Change Control 13.设计确认报告目录Index of ReportIQ INDEX目录1.PURPOSE目的2.RE

16、SPONSIBILITY职责3.LIST OF REFERENCE DOCUMENT 参考文件清单4.EQUIPMENT DESCRIPTION 设备描述5.GENERAL METHODLOGY通用方法：6TEST DESCRIPTION AND ACCEPTANCE CRITERIA 测试描述和可接受标准6.1Prerequisites先决条件6.2Documents Verification 文件确认6.3Safety Verification 安全确认6.4P&ID and Layout Drawing Check P&ID和布局图的检查6.5Equipment List

17、 Check 设备清单检查6.6Instruments List and Instrument Calibration Verification仪表清单和仪表校准的核实6.7Materials and Surface Finishes Check 材料和物体表面的检查6.8Lubricant Verification 润滑剂的确认6.9Drainability Verification 排水能力的确认6.10Utilities Verification 公用设施的确认6.11Control System Electrical Cabinet &Wire Diagram Check控制系

18、统、电气柜和接线图的检查6.12 Software Verification软件的确认6.13 Pickling and Passivation verification酸洗和钝化的检查6.14 Welding Check焊接质量的检查7PERSONNAL IDENTIFICATION人员的鉴别8DEVIATION REPORT偏差报告9COMMENT SECTION注释10LIST OF DEVIATION 偏差清单11LIST OF ATTACHMENT附件清单12EXECUTION REVIEW AND APPROVAL 回顾和批准13MODIFICATION & CHANGE

19、CONTROL 改造和更改控制14 INDEX OF TEST REPORT 测试报告目录OQ目录1.PURPOSE目的2.RESPONSIBILITY职责3.LIST OF REFERENCE DOCUMENT 参考文件清单4.EQUIPMENT DESCRIPTION 设备描述5.GENERAL METHODLOGY通用方法：6.TEST DESCRIPTION AND ACCEPTANCE CRITERIA 测试描述和可接受标准6.1Prerequisites先决条件6.2Qualification Instruments/Calibration Verification仪器校准的确认6

20、.3Safety Verification安全确认6.4Electromagnetic Wave Shield Check电磁波屏蔽的检查6.5Electrical Power Loss Verification失电的确认6.6Loss of Communication通信的丢失6.7Human interface verification人机界面的确认6.8Password verification 口令的确认6.9Digital/Analogue Input & output check 数字/模拟输入& 输出的检查6.10Alarms and Interlocks Che

21、ck报警和联锁检查7.FUNCTION TEST功能测试7.1.Production Parameters Verification生产参数的确认7.2.Peak Flow Verification 最大流量确认8.PERSONNAL IDENTIFICATION人员的鉴别9.DEVIATION REPORT偏差报告10.COMMENT SECTION注释11.LIST OF DEVIATION 偏差清单12.LIST OF ATTACHMENT附件清单13.EXECUTION REVIEW AND APPROVAL 回顾和批准14.MODIFICATION & CHANGE CONT

22、ROL 改造和更改控制13. INDEX OF TEST REPORT 测试报告目录水系统工程验证相关文件清单序号检查文件名称1.设计文件机械部分1.1系统说明1.2P&ID系统图1.3组件清单（包括仪表清单）1.4设备数据表1.5阀门数据表1.6仪表数据表1.7管道数据表1.8水压计算表（管径和流速）1.9管道平面分布图1.10管道轴侧图1.11储罐平面图电气和自控部分1.12电路接线图和气动图（竣工时提供）1.13硬件设计标准（HDS）(控制柜、电路和电气组件的说明)1.14软件设计标准（SDS）(软件配置、控制功能、报警联锁等说明)1.15输入/输出清单1.16功能逻辑图1.17

23、功能说明2.竣工文件2.1系统操作手册2.2组件的文件资料（如泵、阀门、传感器等）2.3材质证明（管道、阀门等）（包括材料种类和表面粗糙度等）2.4焊接文件（包括设备和焊工证书、焊接打印记录、焊样焊点检查记录、焊接规程）2.5仪表校准证书2.6坡度检查规程和报告2.7水压测试规程和报告2.8管道清洗规程和报告2.9管道钝化规程和报告2.10输入输出测试报告2.11报警联锁测试报告2.12单机调试报告2.13系统运行测试报告（功能测试）2.14备品备件清单2.15软件备份3.质量控制文件3.1工程时间进度表3.2需求追溯表3.3风险分析3.4FAT (如储罐)3.5SAT空调系统验证报告文件清单

24、 HVAC设计确认DQ目录 INDEX1.目的Purpose2.职责Responsibility3.设计参考文件清单Reference Documnet4.设备描述 System Description 5.设计确认描述和可接受标准 DQ Description & Acceptance Criteria5.1先决条件Prerequisites5.2设计文件确认 Design Document Verification 5.3安全确认 Safety Verification 5.4房间参数的确认 Room Specification Verification 5.5系统冷负荷的核算 C

25、ooling Capacity Verification 5.6系统热负荷的核算 Heating Capacity Verification 5.7系统加/除湿量的核算 DE/Humidification Verification5.8空调机组性能的确认 AHU Speicification Verification 5.9系统风管和风口布置图（及高效过滤器）的确认 Air Duct & HEPA Layout5.10空调控制系统的确认 Control System Verification 5.11仪器仪表的确认 Instrument Verification 5.12高效过滤器DO

26、P测试设计的确认 DOP design Verification 5.13空调系统GMP的设计审核 GMP Review6.人员的鉴别 Personnel Identification 7.偏差报告 Deviation Report8.注释Comment Section 9.偏差清单 Deviation List10.附件清单 Attachment List11.回顾和批准 Reviesw & Approval12.改造和更改控制 Change Control 14. 设计确认报告目录Index of Report设计确认报告1 先决条件Prerequisites设计确认报告2 设计文

27、件确认Design Document Verification设计确认报告3 安全确认Safety Verification设计确认报告4 房间参数的确认Room Specification Verification设计确认报告5 系统冷负荷的核算Cooling Capacity Verification设计确认报告6 系统热负荷的核算Heating Capacity Verification设计确认报告7 系统加/除湿量的核算DE/Humidification Verification设计确认报告8 空调机组性能的确认AHU Speicification Verification设计确认报告

28、9 系统风管和风口布置图（及高效过滤器）的确认Air Duct & HEPA Layout设计确认报告10 空调控制系统的确认Control System Verification设计确认报告11 仪器仪表的确认Instrument Verification设计确认报告12 高效过滤器DOP测试设计的确认 DOP design Verification设计确认报告13 空调系统GMP 的设计审核GMP Review设计确认报告14 人员的鉴别Personnel Identification设计确认报告15 偏差报告Deviation Report设计确认报告16 注释表Comment

29、Section设计确认报告17 偏差清单 Deviation List设计确认报告18 附件清单 Attachment List设计确认报告 19 批准 ApprovalIQ 目录1.PURPOSE目的2.RESPONSIBILITY职责3.LIST OF REFERENCE DOCUMENT 参考文件清单4.EQUIPMENT DESCRIPTION 设备描述5.GENERAL METHODLOGY通用方法：6.TEST DESCRIPTION AND ACCEPTANCE CRITERIA 测试描述和可接受标准6.1.Prerequisites先决条件6.2.Documents Verif

30、ication 文件确认6.3.Safety Verification 安全确认6.4.P&ID and Layout Drawing Check P&ID和布局图的检查6.5.Equipment List Check 设备清单检查6.6.Instruments List and Instrument Calibration Verification仪表清单和仪表校准的核实6.7.HEPA Filter Layout Check 高效过滤器的检查6.8.Utilities Verification 公用设施的确认6.9.Control System Electrical Cab

31、inet &Wire Diagram Check控制系统、电气柜和接线图的检查6.10.Control System Software Verification软件的确认6.11.Control System Hardware Verification硬件的确认6.12.GMP REVIEW GMP的审核7.PERSONNAL IDENTIFICATION人员的鉴别8.DEVIATION REPORT偏差报告9.COMMENT SECTION注释10.LIST OF DEVIATION 偏差清单11.LIST OF ATTACHMENT附件清单12.EXECUTION REVIEW A

32、ND APPROVAL 回顾和批准13.MODIFICATION & CHANGE CONTROL 改造和更改控制14.INDEX OF TEST REPORT 测试报告目录OQ目录1.PURPOSE目的2.RESPONSIBILITY职责3.LIST OF REFERENCE DOCUMENT 参考文件清单4.EQUIPMENT DESCRIPTION 设备描述5.GENERAL METHODLOGY通用方法：6.TEST DESCRIPTION AND ACCEPTANCE CRITERIA 测试描述和可接受标准6.1Prerequisites先决条件6.2Qualificatio

33、n Instruments/Calibration Verification验证仪器校准的确认6.3Sequence Check顺序确认6.4Electromagnetic Wave Shield Check电磁波屏蔽的检查6.5Black Out Verification 中断的确认6.6Loss of Communication通信的丢失6.7Human interface verification人机界面的确认6.8Password verification 口令的确认6.9Digital/Analogue Input & output check 数字/模拟输入& 输出的检查6.10Alarms and Interlocks Check报警和联锁检查7.ROOM TEST 房间测试7.1.HEPA Fi