Validation_master_plan验证主计划参考.doc

PAGE Pag. PAGE 8 / NUMPAGES 48 VALIDATION MASTER PLAN 验证主计划 (China) Co., Ltd. MANUFACTURING PLANT 有限公司工厂 PREPARED BY: 制定人： QA MANAGER QA经理 CHECKED BY: 审核人： HEAD OF QA 质量经理 APPROVED BY: 批准人： VERSION/版本： VALID DATE/生效日期 Content/目录 TOC \o 1-3 \u 1. INTRODUCTION 简介 5 1.1. Validation policy 验证方针 5 1.2. Aim of the Validation Master Plan (VMP) 验证主计划（VMP）的目的 5 2. LOCATION 位置 7 3. RESPONSIBILITIES 职责 7 4. VALIDATION: FLOW SHEETS AND DEFINITIONS 验证：流程和定义 11 4.1. General criteria 一般标准 11 4.2. Validation flow chart 验证流程图 12 4.3. Operative scheme 实施程序 13 5. ACCEPTANCE CRITERIA 接收标准： 17 5.1. General acceptance criteria for qualifications 确认的一般接收标准 17 5.1.1. Design Qualification (DQ) 设计确认（DQ） 17 5.1.2. Installation Qualification (IQ) 安装确认（IQ） 17 5.1.3. Operation Qualification (OQ) 运行确认（OQ） 18 5.1.4. Performance qualification (PQ) 性能资料（PQ） 19 5.2. Specific acceptance criteria for qualifications 确认的专属接收标准 19 5.3. General acceptance criteria for process validations 工艺验证和一般接收 19 5.4. General acceptance criteria for cleaning validations 清洁验证的一般接收标准 25 5.4.1. Chemical check 化学检查 25 5.4.2. Microbiological check 微生物检查 26 6. QUALIFICATIONS AND VALIDATIONS LISTS 确认和验证清单 27 6.1. List of GMP related building and building services qualifications including level of validation GMP相关的建筑物和厂房服务系统确认清单包括各层水平的验证 27 6.2. List of equipment qualifications including level of validation and critical items 设备确认验证层次的重要项目之清单 28 6.2.1. MANUFACTURING EQUIPMENT 生产设备 28 6.3. List of Quality Control Equipment including the level of qualification 质量控制设备清单 30 6.3.1. Quality Control equipment – Chemical Laboratory 质量控制设备-化学试验室 30 6.3.2. Quality Control equipment – IPC 质量控制设备-中间过程控制室 31 6.3.3. Quality Control equipment – Microbiological Laboratory 质量控制设备 – 微生物试验室 31 6.4. Analytical method validation 分析方法验证 32 6.5. List of products with manufacturing steps 产品清单及生产步骤 33 6.6. List of products including level of process validation 拟进行验证的产品清单 34 6.7. Maintenance of validation 验证维