物料平衡若干问题探讨及对监管工作的启示

Discussion on several problems of mass balance and enlightenment of drug administration

物料平衡检查不是药品生产过程中的唯一质量控制措施,但却是必要的。本文从物料平衡的概念以及药品生产各环节的物料平衡检查等方面阐明了物料平衡管理对保证药品质量的重要性,同时物料平衡检查对药品监管工作起到启示作用。

Mass balance is not single quality control measures in the process of drug production,but it is necessary.From the concept of mass balance and the mass- balance determination in each link of drug production,this paper represented the importance of mass balance management for drug quality assurance,as well as the enlightenment for drug administration.