上市许可持有人制度下非生产企业的药品委托生产质量管理探析

目的：探究上市许可持有人制度下非生产企业的药品委托生产质量管理之有效举措，以供研发机构及科研人员借鉴。方法：阐述上市许可持有人制度出台背景及进展情况，比较现行药品委托生产与上市许可持有人制度下的药品委托生产，通过分析前者的现状及其不足之处，提出上市许可持有人制度下的委托生产中保证药品质量的一系列措施。结果与结论：除详细考察、加强沟通、在委托生产企业配备专职人员外，上市许可持有人还可通过质量源于设计、风险管理等多种手段结合，对委托生产过程进行一体化全面质量管理；设计全面质量体系模型来帮助双方订立详细质量协议。应充分发挥全面质量管理在上市许可持有人制度中的作用。

Analysis of Quality Management of Drug Contract Manufacturing in Marketing Authorization Holder System

Objective: To explore the effective measures for quality management of drug contract manufacturing of non-production enterprises in the marketing authorization holder (MAH) system and to provide references for R&D institutions and researchers. Methods: The background and progress of the MAH system were elaborated, and the differences between the current drug contract manufacturing and that under MAH system were compared. Through the analysis of current situation and shortcomings of the former, a series of measures that can ensure the quality of drugs in contract manufacturing of the MAH system were proposed. Results and Conclusion: In addition to careful inspection, more communications and employing full-time personnel in contract manufacturing companies, MAH could carry out overall quality management of the contract manufacturing process by using the Total Quality Management integrated with multiple methods such as quality by design, risk management and so on. A comprehensive quality system model was designed to help both parties establish detailed quality agreements. The role of Total Quality Management in MAH system should be fully utilized.