中国药业2016，Vol.25Issue(14)：13-15,3.
化学药品无菌制剂生产技术转让案例分析
Case Analysis of Production Technology Transfer of Chemical Sterile Preparation
邓婷 1武小 1宋丹 1杨成钢1
作者信息
- 1. 重庆市药品技术审评认证中心，重庆 400014
- 折叠
摘要
Abstract
Objective To better promote the production technology transfer of chemical sterile preparation. Methods The typical case of problems were analyzed,the outstanding problems often encountered in production technology transfer process of chemical sterile preparation were summed up,the proposals were put forward to promote the technology transfer. Results and Conclusion The entire process of production technology transfer should be based on risk assessment,the documents for reviewing should be truthful,rigorous, logical,to maintain consistency of product quality. If there are any changes,it should design scientific and rational solutions that combine with relevant laws,regulations and guidelines,to reflect the legitimacy,rationalness and scientificness of the transfer process.关键词
无菌制剂/生产技术转让/风险评估/变更管理Key words
sterile preparation/production technology transfer/risk assessment/change management分类
医药卫生引用本文复制引用
邓婷,武小,宋丹,杨成钢..化学药品无菌制剂生产技术转让案例分析[J].中国药业,2016,25(14):13-15,3.
