/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm
中文译稿：北京大学药物信息与工程研究中心 info@
另外的副本可从以下部门得到： 马里兰州银泉市新罕布什尔大道10193号2201室 药品信息处，对外信息办公室， 邮政编码：20993 电话：301-796-3400; 传真：301-847-8714
Guidance for Industry
行业指南 Process Validation: General Principles and Practices 工艺验证：一般原则与规范
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Veterinary Medicine (CVM) January 2011 Current Good Manufacturing Practices (CGMP) Revision 1 美国卫生与人类服务部 食品药品管理局 药物评价和研究中心（CDER） 生物制品评价和研究中心（CBER） 兽药中心（CVM） 2011年1月 现行药品质量生产管理规范（CGMP） 修订版 1
/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
and/or Communications Staff, HFV-12 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 (Tel) 240-276-9300
/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
和/或 马里兰州洛克维尔市Standish Place 7519号食品药品管理局兽药中心HFV-12通讯处，邮政编码：
中文译稿：北京大学药物信息与工程研究中心 info@
Table of Contents 目录
I. INTRODUCTION......................................................................................................................................... 1 一. 简介 ........................................................................................................................................................... 1 II. BACKGROUND .......................................................................................................................................... 3 二. 背景 ........................................................................................................................................................... 3 A. Process Validation and Drug Quality .................................................................................................. 4 A. 工艺验证与药品质量 .................................................................................................................... 4 B. Approach to Process Validation ......................................................................................................... 5 B. 工艺验证方法 ................................................................................................................................. 5 III. STATUTORY AND REGULATORY REQUIREMENTS FOR PROCESS VALIDATION ............................... 7 三. 对工艺验证的法规和监管要求 ........................................................................................................... 7 IV. RECOMMENDATIONS ............................................................................................................................... 9 四. 建议 ........................................................................................................................................................... 9 A. General Considerations for Process Validation .................................................................................. 9 A. 对工艺验证的总体考虑 ............................................................................................................... 9 B. Stage 1 - Process Design................................................................................................................. 10 B. 第一阶段 - 工艺设计 ................................................................................................................. 10 1. Building and Capturing Process Knowledge and Understanding ............................................ 11 1. 建立和捕获工艺知识与理解 ............................................................................................ 11 2. Establishing a Strategy for Process Control ............................................................................ 12 2. 建立工艺控制策略 ............................................................................................................. 12 C. Stage 2 - Process Qualification ........................................................................................................ 14 C. 第二阶段 - 工艺确认 ................................................................................................................. 14 1. Design of a Facility and Qualification of Utilities and Equipment ............................................. 14 1. 厂房设施设计以及公用设施与设备确认 ...................................................................... 14 2. Process Performance Qualification ......................................................................................... 16 2. 工艺性能确认 ...................................................................................................................... 16 3. PPQ Protocol........................................................................................................................... 17 3. 工艺性能确认方案 ............................................................................................................. 17 4. PPQ Protocol Execution and Report ....................................................................................... 19 4. 工艺性能确认执行与报告 ................................................................................................ 19 D. Stage 3 - Continued Process Verification ......................................................................................... 20 D. 第三阶段 - 持续工艺验证 ........................................................................................................ 20 V. CONCURRENT RELEASE OF PPQ BATCHES ....................................................................................... 22 五. 工艺性能确认批次的同时放行 ......................................................................................................... 22 VI. DOCUMENTATION ................................................................................................................................... 24 六. 文件记录................................................................................................................................................. 24 VII. ANALYTICAL METHODOLOGY ............................................................................................................... 24 七. 分析方法................................................................................................................................................. 24 GLOSSARY .................................................................................................................................................... 26 术语表 ........................................................................................................................................................... 26 REFERENCES................................................................................................................................................ 28 参考资料....................................................................................................................................................... 28