摘要
URS是设备采购的重要技术资料,针对新版GMP规范要求,结合冻干机系统及无菌制药工艺特点制定相关URS。
URS is important document in procurement of equipment. With the requirement specified in new version GMP code, how to establish URS, which is based on freezing dryer and the characteristics of aseptic pharmaceutical process, was illustrated in this article.
出处
《医药工程设计》
2013年第4期35-40,共6页
Pharmaceutical Engineering Design
