欧盟新版无菌药品附录主要变化点及对我国无菌药品生产管理的启示

The Main Changes of EU GMP Annex1 and Revelation to Pharmaceutical Manufacturers in China

目的:通过比对分析提出工作建议,为国内无菌生产企业进一步提升无菌管理水平提供借鉴。方法:介绍最新版欧盟无菌药品附录的一些主要变化点,对比分析欧盟和我国在无菌药品方面的异同。结果与结论:欧盟无菌附录在适用范围、污染控制体系(CCS)、环境监测和工艺监测、部分生产和生产具体技术等方面较原有版本和我国要求有较大提升。国内无菌生产企业应重视欧盟无菌附录的变化,逐步加强无菌管理,大力推进无菌生产企业的国际化进程。

Objective:By analyzing and comparing the draft of Annex 1“Manufacture of Sterile Medicinal Products”in EU GMP,in order to get suggestions on the implementation of GMP in China.Methods:By introducing the main changes of Annex 1“Manufacture of Sterile Medicinal Products”in EU GMP,comparing the differences.Results and Conclusion:Comparing with last version and GMP in our country,EU GMP has improved a lot in scope,CCS,Production and specific technologies,Environmental and process monitoring and so on.Local manufacturers should pay attention to the changes of EU GMP,in order to improve the internationalization level.