摘要
在药品检验机构实验室建立变更控制体系,采用系统化的变更控制手段,对管理体系发生变化的过程及其可能造成的影响实施有效控制,可以大大提高管理水平,降低质量风险,保证管理体系持续改进的平稳、有效推进。本文总结中国食品药品检定研究院变更控制系统建立的实践经验,结合将实验室检定业务管理信息系统升级项目纳入变更控制体系中进行管理中的典型案例,对药品检验机构实验室变更控制程序的编制要点和变更控制实施的操作方法进行分析阐释,为药检实验室开展变更控制管理提供参考。
The establishment of change control system and the usage of systematic change control methods in drug control institutes can greatly improve the management level, reduce the quality risk, and ensure the smooth and effective operation of the management system for continuous improvement. This paper summarized the practical experience of the establishment of change control system in the National Institutes for Food ＆ Drug Control, studied the typical case of the implementation of change control in the laboratory test business management information system upgrade project, analyzed the key points of the preparation of the change control procedure and the practical change control operation methods, with the purpose of providing reference for drug control institutes to carry out the change control management.
出处
《中国医药导报》
CAS
2016年第25期165-169,共5页
China Medical Herald
关键词
药品检验
质量管理
变更控制
Drug inspection
Quality management
Change control
