新版GMP规范下无菌制剂洗烘灌封联动分装线URS  

Distributing Packaging Line Conformed with New GMP and Integrated with Functions of Cleaning,Stoving,Filling and Packaging

作　　者：史云[1] 赵兴平[1] 

机构地区：[1]中国医学科学院医学生物学研究所,云南昆明650118

出　　处：《医药工程设计》2013年第2期33-37,共5页Pharmaceutical Engineering Design

摘　　要：URS是设备采购的重要技术资料,针对新版GMP规范要求,结合洗烘灌封联动分装线系统及无菌制药工艺特点制定相关URS。User Requirement Specification （URS） is important technical information for equipment procurement. With respect to the requirements in new GMP and combined with the features of integration system with functions of washing, sterilizing, filling and packaging and aseptic process, in this article, the relevant URS was established.

关 键 词：URS 洗烘灌封联动分装线 GMP 

分 类 号：R95[医药卫生—药学]