EMA最新工艺验证指南解读_丁恩峰.pdf

　药厂与GMP 20 12年　第33卷　第5期　10月20 日出版 医药工程设计 · · Pharmaceutical Engineering Design 2012 ， 33(5) EMA最新工艺验证指南解读 丁恩峰　高海燕 （英国施达化学集团公司中国代表处，河北石家庄　050031；北京赛铭医药科技有限公司，河北石家庄　050031） 摘要 2008 年 11 月，FDA 发布 了最新工艺验证指南，引起制 药行业对这个热点话题的高度关注；2011 年 1 月，FDA 结束征集意见，发布 了新版工艺验证指 南的最终稿。作为世界制 药行业的另外一个著名监 管机构，EMA 也于 2012 年 3 月发布 了最新的工艺验证指南；这个指南对 EMA 原有工艺验证指南和 ICH 相关指南进行 了整合和梳理，也必 将对制 药行业产生深远影响。笔者对这个指南文件进行翻译和 系统研 究，撰 写此文，希望可以为 中国制 药行业提供 借鉴和帮助。 关键词 FDA ；EMA ；工艺验证 ；工艺设计；工艺性能确认 ；持续工艺核 实；生命周期；混合方法；工艺放 大；非标准 工艺 中图分类号： R951 文献标识码：A 文章编号： 1008-455X(2012) 05-0037-05 Explanation and Discussion of Newest EMA Process Validation Guide Ding Enfeng　Gao Haiyan 1. China Representative Office, Great Briton Shida Chemical Group Co. Shijiazhuang, 050031; （ 2. Beijing Spring PharmaTech Inc. Beijing, ） Abstract: In November, 2008, the newest process validation guide was issued by FDA, which was highly focused in pharmaceutical industry. In January, 2011, collection of the opinions for this version of guide was ended and the final version was, then, issued. As another famous supervision organization in pharmaceutical industry, EMA also issued an new process validation guide in March, 2012. In this guide, original EMA process validation guide and relevant ICH guide were sort out and combined, which may produce great influence in the field. The author translated and systematically studied this guide and completed this article. It is hopeful to provide the reference for the enterprises in pharmaceutical industry. Keywords: FDA; EMA; process validation; process design; process performance qualification; continuous process verification; life