中药新药“生产现场检查用生产工艺”撰写中需关注的问题

Problems in writing production process in production site inspection of new TCM drugs

根据《药品注册管理办法》相关规定,中药新药生产注册申请批准前需要进行生产现场检查,这要求研发者在申请中药新药生产注册的同时,须提交新药"生产现场检查用生产工艺"。撰写良好的"生产现场检查用生产工艺"资料工作非常重要,它既决定新药生产注册申请能否顺利获得批准,又决定新药制剂上市后工业化生产的可行性、稳定性及可持续性,更是接受食品药品监管部门监督检查的法定文件。本文通过分析目前撰写"生产现场检查用生产工艺"资料中存在的问题,分别从撰写"生产工艺"重要性、撰写"生产工艺"一般原则、撰写"生产工艺"中原料问题、制备工艺问题、内控标准问题、"特殊工艺"问题及撰写"生产工艺"不完整、不规范问题等方面阐述了研发者需关注的问题。

According to the relevant provisions of ＂drug registration regulation＂, production site inspection is required before registration approval for production of new TCM drugs. A developer is required to submit their new drug ＂production process in production site inspection＂ at the same time of application for registration of new drug of TCM. Writing a satisfactory ＂production process in production site inspection＂ is very important. This is decided to approve new drug production smoothly according to the application for registration, to relate to the feasi- bility of the new drug preparations after industrialized production, stability and sustainability, and to accept the su- pervision and inspection by the food and drug regulatory legal documents, in this paper, we analyzed the current status of writing ＂production process in production site inspection＂; the problems existed in the importance, gener- al principles, raw materials, preparation technology, and internal control standards in the writing ＂ production process＂, as well as ＂special process＂, incomplete writing and non-standard aspects. This paper expounded those should be concerned by the developers.