浅论扩大化的工艺验证

Discussion of Process Enlargement Validation

目的:通过学习和研究美国FDA发表的工艺验证指南,思考我国在工艺验证方面的工作,借鉴美国先进经验结合我国工艺验证的实施现状,总结出适合现阶段我国制药企业的工艺验证思路。方法:在对美国cGMP工艺验证指南深入理解的基础上,对比我国目前工艺验证现状以及我国现阶段对工艺验证的理解,分析国内外工艺验证的差异,从而寻求我国相关法律法规的完善。结果:通过对美国cGMP工艺验证指南的深入理解和国际标准的准确把握,完成了扩大化工艺验证的学习和思考。结论:总结出扩大化工艺验证与传统的工艺验证的不同,为我国制药企业对验证特别是工艺验证概念的理解提供条件。

Objective： By studying the process validation guidance issued by USA FDA, the work in process validation in our country will be discussed. Referenced with experiences in USA and combined with the current situation of process validation in our country, the validation method which is adapted to use in china is summarized. Method： Based on in-depth understanding of USA cGMP process validation guidance, compared with the current situation of process validation in our country, the differences existed in process validation in USA and in China were compared, then, the improvement of relevant regulations and laws were found. Result and conclusion： Through in-depth understanding of USA cGMP process validation guidance and international standards, the learning of enlarged chemical process validation has been completed, so that the differences existed in process validation in USA and in China were summarized, which can be referenced for the enterprises in China to understand the concept of validation, especially of process validation.