对药品生产企业GMP评级的探讨

Discussion of GMP Grading for Drug Production Enterprises

目的:通过对生产企业GMP进行评级,提出改进我国对药品生产企业GMP监管的新思路。方法:通过绩效管理中的一些技术方法,结合GMP管理特点,对企业GMP管理水平进行评定。结果与结论:由于企业间GMP管理水平存在着巨大差别,进行GMP管理评级,对GMP监管将产生的积极影响,进行评级工作很有必要。

Objective： Through the GMP grading for enterprises, to propose new idea of GMP supervision for the drug enterprises in China. Method： Through some technical method used in merit and efficiency administration and combined with the characteristics of GMP administration, the GMP administration level of enterprises was graded. Result and conclusion： Because there is large difference of GMP administration level existed in enterprises, GMP administration grading will make positive influence to GMP supervision. The grading is necessary.