化学药品注射剂灭菌工艺选择及工艺验证常见问题探讨  

Discuss on the choose and common problems of sterilization process of injection

作　　者：谢纪珍[1] 冯巧巧[1] 刘军田[1] 周冲 马铃铃 XIE Jizhen;FENG Qiaoqiao;LIU Juntian;ZHOU Chong;MA Lingling(Shandong Food and Drug Administration Center for Evaluation and Certification,Jinan 250014,China)

机构地区：[1]山东省食品药品监督管理局审评认证中心,山东济南250014

出　　处：《药学研究》2018年第6期370-372,共3页Journal of Pharmaceutical Research

摘　　要：注射剂的灭菌是保证制剂质量和用药安全的重要工艺步骤,本文结合日常技术审评经验,从灭菌工艺选择、工艺验证内容及工艺验证中常见问题等方面,对化学药品注射剂灭菌工艺选择及验证中常见问题进行探讨。Sterility is an important process for quality control and safety of injection,in this paper,the choose and common problems of sterilization process of injection,such as choose and validation of sterilization process,common problems in sterilization process of injection were discussed,based on the daily evalution experiences.

关 键 词：灭菌工艺选择 工艺验证 常见问题 

分 类 号：TQ460.6[化学工程—制药化工]