FDA最新工艺验证指南深度解析

Detailed Analysis of Guide to Validation of Newest FDA Process

工艺验证是制药企业实施GMP规范的关键问题。一个工艺是否成熟和稳定,是否可以持续生产出符合质量要求的产品,取决于工艺验证的深度和广度。1987年,FDA发布了关于工艺验证的指南文件。FDA关于工艺验证的要求和理解深深地影响着世界各国药政当局和制药行业。2008年11月,FDA再次发布最新的工艺验证指南(草案),对工艺验证的概念和要求进行了大幅度地修改和更新。笔者通过查阅FDA网站资料,对FDA最新工艺验证指南(草案)进行深度解读和评析,并汇总其他著名制药企业和行业协会关于这个指南地评价意见,有利于对这个指南文件进行系统研究。

Process validation is a key in execution of GMP in pharmaceutical enterprise. Whether a process is stable and mature enough and whether qualified products can be produced continuously lie in the scope of the process validation. In 1987, a guide document was issued by FDA. FDA’s requirements and understanding for process validation influence pharmaceutical industry deeply. In November, 2008, a new guide to process validation was issued again by FDA, in which the concepts and requirements of process validation were modified and updated. By consulting the information from FDA net station, in this article, the author analyzed the latest version of the guide of process validation issued by FDA in detail and su mmarized the opinions and evaluations of this guide from a variety of remarkable pharmaceutical enterprises. What presented herein may be referenced in systematical research of this guide document.