关于化学药品注册批量问题的探讨

Discussion on the issues of batch size for registration of chemical drug

在化学药品注册中,批量以及生产规模放大是药学审评重点关注的问题。本文在对"批"定义进行剖析的基础上,比较了国内外对工艺开发批量的要求,总结了质量研究、稳定性研究、非临床研究、临床研究所用批次的批量要求,并提出了进一步完善我国与批量相关的管理和技术要求的建议。

For the registration of chemical drug,batch size and scale-up are the key concerns of CMC review. In this article,we analyzed the definition of ＂batch＂,compared the domestic requirements for batch size during process development with the foreign,summarized the requirements for batch size of those batches used in validation of analytical procedures,stability,non-clinical and clinical studies,and put forward some suggestions to further improve the relevant domestic management and technical requirements for batch size.