摘要
目的:通过实际案例研究找寻ICH Q13指南背后的基本原理,促进连续制造技术在我国制药行业的应用。方法:以原料药碳酸钙生产为实例,分析其连续制造生产线中部分工序的连续生产设计与实现方式,并参照ICH Q13指南的要求,提出监管层面的考虑。结果与结论:类似于碳酸钙这种工艺简单的品种非常适合转化为先进的连续制造工艺,现有条件可实现部分工序连续生产,也非常有望实现真正的全过程连续制造,为药品连续制造在我国的顺利落地实施提供了实践参考。
Objective:To study and find out the principles of ICH Q13 by analyzing calcium carbonate production as a case in order to promote continuous manufacturing application in China.Methods:By taking the production of calcium carbonate materials as an example,this study analyzed the continuous process design and its implementation of some processes in the continuous manufacturing production line and put forward some considerations about regulation based on the requirements of ICH Q13 guidelines.Results and Conclusion:For such a simple process as calcium carbonate production,it is very suitable to transform it into advanced continuous manufacturing process.The continuous production of some processes can be realized under the existing conditions.It is very promising to realize the real continuous manufacturing of the whole processso so as to provide practical references for the smooth implementation of continuous pharmaceutical manufacturing in China.
作者
曹辉
葛渊源
陈刚
胡延臣
王亚敏
Cao Hui;Ge Yuanyuan;Chen Gang;Hu Yanchen;Wang Yamin(Shanghai Center for Drug Evaluation and Inspection,Shanghai 201203,China;Shanghai Calcium Carbonate Factory Co.,Ltd.,Shanghai 201806,China;Center for Drug Evaluation,NMPA,Beijing 100022,China)
出处
《中国药事》
CAS
2022年第4期384-390,共7页
Chinese Pharmaceutical Affairs
基金
国家重点研发计划《PAT相关的药品监管法规草案和实施指南》(编号2017YFF0210100)。
关键词
碳酸钙
监管考量
连续制造
应用
calcium carbonate
regulatory considerations
continuous manufacturing
application
