中国药物经济学2023，Vol.18Issue(11)：17-20,4.DOI:10.12010/j.issn.1673-5846.2023.11.003
药品上市许可持有人制度下受托生产企业的质量体系建设
Quality System Building of Pharmaceutical Contract Manufacturing Organizations under the Background of Marketing Authorization Holder Policy
吴晓燕 1黄哲1
作者信息
- 1. 沈阳药科大学工商管理学院,沈阳 110179
- 折叠
摘要
Abstract
This paper analyzes the problems existing in the quality management systems of pharmaceutical contract manufacturing organizations under the background of marketing authorization holder(MAH)system in China.It proposes that contract manufacturing organizations need to establish a new operating model on the basis of their current quality management system.This includes building a Phase-Appropriate Quality System,technology transfer process,and quality information exchange mechanisms with MAH.The analysis and recommendations in this study provide insights and references to pharmaceutical contract manufacturing organizations for improving the quality management system.关键词
药品上市许可持有人制度/药品受托生产企业/技术转移/质量管理体系/质量沟通机制Key words
Marketing Authorization Holder/Pharmaceutical Contract Manufacturing Organizations/Technical transfer/Quality system/Quality information exchange mechanisms分类
医药卫生引用本文复制引用
吴晓燕,黄哲..药品上市许可持有人制度下受托生产企业的质量体系建设[J].中国药物经济学,2023,18(11):17-20,4.
