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

本文分析了在药品上市许可持有人(MAH)制度下,国内受托生产企业现有质量体系所存在的问题,提出了受托生产企业需要在原有质量管理体系的基础上建立新的运行模式,包括建立阶段性质量管理体系、技术转移制度和与持有人质量信息互通等方面的新管理方式与流程,为受托生产企业质量体系提升提供建议参考。

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.