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戈U目录（VMP ）1 INTRODUCTION 序言2 REFERENCES 参考2.1 GMP Rules and guideli nes GMP法规和指南2.2 Design documents设计文件3 FACILITY OVERVIEW厂房概要3.1 Production Areas 生产区3.2 R&D and QC Laboratories研发和 QC 实验室3.3 Warehouse 仓库4 XXXX MANUFACTURING PROCESS DESCRIPTION XXX生产工艺描述5 Areas Classificati on区域分类5.1

2、Clea nlin ess Area Classificatio n洁净区分类5.2 HVAC Systems 空调系统5.2.1 XXXX Production Areas XXXX生产区6 Personnel and material Flow人流和物流6.1 Personnel flow 人流6.2 Material Flow 物流7 Pressure Lay Out压力分布图8 UTILITIES 公用设施9 CRITICAL PROCESS STEPS and CRITICAL EQUIPMENT关键的工艺步骤和关键设备8.1.1Purified Water 纯水8.1.2Proce

3、ss air 工艺用空气8.1.3Pure Nitrogen 纯氮8.2 TECHNICAL UTILITIES 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8.3 SUPPORT SYSTEMS 配套系统8.3.1PROCESS SEWER

4、工艺废水8.3.2EQUALISATION/NEUTRALISATION SYSTEM 中和系统8.3.3GASEOUS 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10 VALIDATION APPROACH验证方法10.1GMP Review GMP审核10.2Design Qual

5、ification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计算机系统

6、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)性能确认可接受标准10.13.1 PQ Acceptance Criteria10.14Process Validation工艺验证工艺验证可

7、接受标准清洗验证的可接受标准确认工作的特定的可接受标准空调系统、层流装置和房间的装饰纯化水生产、存储和分配罐和内容物溶液配制罐原料、 XXXX 和内容物10.14.1 Process Validation工艺验证10.14.2 Process Validation Acceptance criteria10.15 Cleaning Validation清洗验证10.15.1 Cleaning Validation清洗验证10.15.2 Cleaning Validation Acceptance criteria10.16 Specific acceptance criteria for Qu

8、alification10.16.1 HVAC, LAF and Architecture Room Finishing10.16.2 Purified Water Production, Storage and Distribution 系统10.16.3 Compressed Air 压缩空气10.16.4 Nitrogen 氮气10.16.5 Scales 称量装置10.16.6 XXX Melter and Filling solution Preparation TankXXX10.16.7 Raw material,XXXX and Filling solution Holding

9、 Tanks 溶液保存罐10.16.8 XXXX Base turbo mixer XXXX着色器10.16.9 XXX machineXX 机10.16.10 Tumble 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10.16.16 Blistering machine

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

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

12、lity Co ntrol质量控制15.4 Project Ma nager 项目经理15.5 Production Ma nager生产经理15.6 Con tractors合同商16 SUPPORT SERVICES 支持性服务16.1 Trai ning 培训16.2 Preve ntive maintenance预防性维护保养16.3 Calibratio n 校准重新验证时间安排Water System17 RE-QUALIFICATION/VALIDATION SCHEDULE18 LIST OF ATTACHMENTS附件清单水系统验证报告文件清单设计确认DQ1. 目的 Purp

13、ose2. 职责 Responsibility3. 设计参考文件清单 Refere nee Docume nt List4. 设备描述 System Description5. 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 Verification5.3 安全确认 Safety Verification5.4 系统温度的确认 Temperature Verification5.5 系统流速和生产能力的确认 Velocity & Capac

14、ity Verification5.6 仪表确认 Instrument Verification5.7 材料和物体表面的检查 Material & Surface fininshing Verification5.8 润滑剂的确认 Lubricant Verification5.9 排水能力的确认 Drainablity Verification5.10 系统设备、管道、联结件结构的确认 Main Compoment, Piping & JointerVerification5.11 控制系统的确认 Control System Verification5.12 系统安装焊接工作要求的确认 W

15、elding Verification5.13 系统清洗和钝化的确认 Pickling and Passivation Verification5.14 系统在线灭菌能力的确认 SIP Verification6. 人员的鉴别 Personnel Identification7. 偏差报告 Deviation Report8. 注释 Comment9. 偏差清单 Deviation List10. 附件清单 Attachment List11. 回顾和批准 Review & Approval12. 改造和更改控制Change Control13. 设计确认报告目录 Index of Repor

16、tIQ INDEX 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 Verification文件确认P&ID 和布局图的检查6.3 Safety Verification安全确认6.4 P&ID and Layout

17、 Drawing Check6.5 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 Materials and Surface Finishes Check材料和物体表面的检查6.8 Lubricant Verification 润滑剂的确认6.9 Drainability Verification排水能力的确认6.10 Utilities Verification公用设施的确认6.11 Control System Electrica

18、l Cabinet &Wire Diagram Check 控制系统、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 偏差清单回顾和批准11 LIST OF ATTACHMENT 附件清单12 EXECUTION RE

19、VIEW AND APPROVAL改造和更改控制13 MODIFICATION & CHANGE CONTROL14 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6.1 Prerequisites 先决条件6.2 Qualific

20、ati on In strume nts/Calibratio n Verificatio n仪器校准的确认6.3 Safety Verificati on安全确认6.4 Electromag netic Wave Shield Check电磁波屏蔽的检查6.5 Electrical Power Loss Verificatio n失电的确认6.6 Loss of Commu ni cati on通信的丢失6.7 Huma n in terface verificati on人机界面的确认6.8 Password verificatio n口令的确认6.9 Digital/A nalogue

21、In put & output check数字 / 模拟输入& 输出的检查6.10Alarms and In terlocks Check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 ATTACHM

22、ENT 附件清单13. EXECUTION REVIEW AND APPROVAL 回顾和批准14. MODIFICATION & CHANGE CONTROL 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）（

23、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

24、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 HVAC设计确认DQ目录INDEX1. 目的 Purpose2. 职责 Responsibility3. 设计参考文件清单 Referenee Documnet4. 设备描述 System Description5. 设计确认描述和可接受标准DQ Description & Aeeepta nee Criteria5.1 先决条件 Prerequisites5.2 设计文件确认 Design Doeument Verification5.3 安全

25、确认 Safety Verifieation5.4 房间参数的确认 Room Speeifieation Verifieatio n5.5 系统冷负荷的核算 Cooli ng Cap aeity Verifieati on5.6 系统热负荷的核算 Heati ng Cap aeity Verifieati on5.7 系统加 / 除湿量的核算 DE/Humidifieatio n Verifieati on5.8 空调机组性能的确认 AHU Speieifieation Verifieati on5.9系统风管和风口布置图（及高效过滤器）的确认 Air Duet & HEPA Layout5.

26、10 空调控制系统的确认 Co ntrol System Verifieation5.11 仪器仪表的确认 In strume nt Verifieation5.12 高效过滤器 DOP 测试设计的确认 DOP design Verification5.13 空调系统 GMP 的设计审核 GMP Review6. 人员的鉴别 Personnel Identification7. 偏差报告 Deviation Report8. 注释 Comment Section9. 偏差清单 Deviation List10. 附件清单 Attachment List11. 回顾和批准 Reviesw & A

27、pproval12. 改造和更改控制 Change Control14. 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 Verificatio

28、n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9 系统风管和风口布置图（及高效过滤器）的确认 Air Duct & HEPALayout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 designVerification设计确认报告13 空调系统

29、 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 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.

30、 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 Verification文件确认6.3. Safety Verification安全确认6.4. P&ID and Layout Drawing CheckP&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

31、 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 Cabi net &Wire Diagram Check控制系统、电气柜和接线图的检查6.10. Control System Software Verificatio n软件的确认6.11. Con trol System Hardware Verificati on硬件的确认6.12. GMP REVIEW GMP 的审核7. PERSONNAL IDENTIFI

32、CATION 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 AND 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. EQUI

33、PMENT 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 Qualification Instruments/Calibration Verification验证仪器校准的确认6.3 Sequence Check 顺序确认6.4 Electromagnetic Wave Shield Check电磁波屏蔽的检查6.5 Black Out Verification中断的确认6.6 Loss of Communication通信的丢失6.7 Human interface verification人机界面的确认6.8 Password verification口令的确认6.9 Digital/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.HE