摘要
新版药品GMP引入了变更控制这一先进的质量管理体系。作为制药企业如何贯彻法规要求,建立变更控制管理体系是企业面对的主要问题。阐述变更控制的概念、范围和变更的分类,分析变更控制管理流程和管理过程中的难点,期望为药品生产企业的变更控制管理提供参考。
The change control,an advanced quality management system is as a part of the new revision GMP of China.According to the new statute,how to establish the change control quality management system is a major problem that pharmaceutical manufacturer faced.To elaborate the change control concept,range and class,and analyze the change control management process and difficulty.In expectation,it will be referred for pharmaceutical manufacturer.
出处
《河北化工》
2011年第7期30-32,64,共4页
Hebei Chemical Industry
