工程验证和o相关文件清a单.docVIP

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 RD 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 Classification 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 Process 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 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 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 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 acceptance 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 Proce