生物制品包装系统密封性研究的探讨  

Discussion on the container closure integrity of biological products

作　　者：王雪 韦薇 WANG Xue;WEI Wei(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076

出　　处：《中国新药杂志》2025年第6期665-668,共4页Chinese Journal of New Drugs

摘　　要：包装系统密封性,又称容器密封完整性,包装系统密封性研究是药物开发的重要组成部分。本文重点论述了生物制品的包装系统密封性研究的总体考虑及其生命周期的管理,以供研究者参考。Package integrity is also known as container-closure integrity(CCI).Research on CCI is an important part of drug development.This article focuses on the overall considerations of CCI research and its life cycle management for reference.

关 键 词：生物制品 包装系统密封性 容器密封完整性 产品生命周期 

分 类 号：R95[医药卫生—药学]