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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5.1Cleanliness A
2、rea 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 UTILIT
3、IES 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8.3.3GASEOU
4、S 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 Qualifica
5、tion 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
6、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 工艺验证
7、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 Architecture
8、 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、XXXX和
9、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铝塑包装
10、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 SOPS标准操作程序清单14QUALIFICATION/VALIDATION METHODOLOGY验证方法14.
11、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 Control质量控制15.4Project Mana
12、ger项目经理15.5Production Manager 生产经理15.6Contractors 合同商16SUPPORT SERVICES支持服务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.设计参考文件清单 Reference Documen
13、t 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 Instrument Verification 5.7材料和物体表面
14、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 5.13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 Repor
