工程验证跟相关文件清单.docx

1、工程验证跟相关文件清单工程验证及相关文件目录验证主计划目录 （VMP）1 INTRODUCTION序言 2 REFERENCES 参考 2.1 GMP Rules and guidelines 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 Class

2、ification 区域分类 5.1 Cleanliness Area Classification 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 8.1 Process Utilities 工艺用公用设施 8.1.1 Purified Water 纯水 8.1.2 Proc

3、ess air 工艺用空气 8.1.3 Pure Nitrogen纯氮 8.2 TECHNICAL UTILITIES 技术用公用设施 8.2.1 POTABLE WATER (W) SYSTEM饮用水系统 8.2.2 HOT WATER FOR HVAC (HWS)空调用热水系统 8.2.3 HOT SANITARY WATER (HSWS)卫生型热水 8.2.4 MEDIUM AND LOW PRESSURE STEAM中压和低压蒸汽 8.2.5 COMPRESSED AIR压缩空气 8.2.6 CHILLED WATER冷冻水 8.3 SUPPORT SYSTEMS 配套系统 8.3.1

4、 PROCESS SEWER工艺废水 8.3.2 EQUALISATION/NEUTRALISATION SYSTEM中和系统 8.3.3 GASEOUS EFFLUENTS HANDLING气体处理系统 8.3.4 FIRE WATER SYSTEM消防系统 8.3.5 FOAM SYSTEM消防泡沫系统 8.3.6 DRY CHEMICAL SYSTEM干粉系统 8.3.7 CARBON DIOXIDE SYSTEM二氧化炭系统 8.3.8 FIRE-FIGHTING SYSTEM SELECTION火灾报警系统 9 CRITICAL PROCESS STEPS and CRITICAL

5、EQUIPMENT 关键的工艺步骤和关键设备 10 VALIDATION APPROACH 验证方法 10.1 GMP Review GMP审核 10.2 Design Qualification 设计确认 10.3 Factory Acceptance Test 工厂验收测试 10.4 Mechanical completion 机械性完工 10.5 Calibration 校准 10.6 Commissioning 调试 10.7 Site Acceptance Test 现场验收测试 10.8 Validation Turn over package (Vtop) 验证文件包 10.9

6、Installation Qualification 安装确认 10.9.1 IQ Acceptance Criteria可接受标准 10.10 Computer Installation Qualification 计算机系统的安装确认 10.10.1 CIQ acceptance criteria 可接受标准 10.11 Operational Qualification 运行确认 10.11.1 OQ Acceptance Criteria运行确认的可接受标准 10.12 Computer Operational Qualification计算机运行确认 10.12.1 COQ acce

7、ptance criteria可接受标准 10.13 Performance Qualification (PQ) 性能确认 10.13.1 PQ Acceptance Criteria可接受标准 10.14 Process Validation 工艺验证10.14.1 Process Validation 工艺验证 10.14.2 Process Validation Acceptance criteria 工艺验证可接受标准 10.15 Cleaning Validation 清洗验证 10.15.1 Cleaning Validation 清洗验证 10.15.2 Cleaning Va

8、lidation Acceptance criteria 清洗验证的可接受标准 10.16 Specific acceptance criteria for Qualification 确认工作的特定的可接受标准 10.16.1 HVAC, LAF and Architecture Room Finishing空调系统、层流装置和房间的装饰 10.16.2 Purified Water Production, Storage and Distribution 纯化水生产、存储和分配系统 10.16.3 Compressed Air 压缩空气 10.16.4 Nitrogen 氮气 10.16.

9、5 Scales 称量装置 10.16.6 XXX Melter and Filling solution Preparation TankXXX罐和内容物溶液配制罐 10.16.7 Raw material,XXXX and Filling solution Holding Tanks 原料、XXXX和内容物溶液保存罐 10.16.8 XXXX Base turbo mixer XXXX着色器 10.16.9 XXX machine XX机 10.16.10 Tumble Dryer 转筒式干燥机 10.16.11 Drying Tunnel 干燥隧道 10.16.12 Sorting ma

10、chine 拣丸机 10.16.13 XXXXs Washing machine (Future) 洗丸机 10.16.14 XXXX printing machine(Future) XXXX打字机 10.16.15 Optical inspection machine目检机 10.16.16 Blistering machine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.

11、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 METHODOLOGY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 &

12、 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 Manager技术总监 15.2 Quality Assurance/Control经理 15.3 Quality Control质量控制 15.4 Project Manager项目经理 15.5 Production Manager 生产经理 15.6 Contractors 合同商 16 SUPPORT SERVICES支持性服务 16.1 Tr

13、aining培训 16.2 Preventive maintenance预防性维护保养 16.3 Calibration校准 17 RE-QUALIFICATION/VALIDATION SCHEDULE重新验证时间安排18 LIST 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Purpose 2. 职责 Responsibility 3. 设计参考文件清单 Reference Document List 4. 设备描述 System Description 5. 设计确认描述和可接受标准 Design Description

14、 & Acceptance Ctiteria5.1 先决条件Prerequisites 5.2 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 Instrument Verification 5.7 材料和物体表面的检查 Material & Surface fininshing Verification 5.8 润滑剂的确

15、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 5.13 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 List 11. 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