论药品生产企业质量方针与GMP管理的衔接

On Linking GMP with Quality Management Policy in Pharmaceutical Enterprises

目的:探讨药品生产企业质量方针与GMP衔接的方法。方法:从质量管理原理和GMP标准要求出发,分析GMP与质量方针衔接的可能性与必要性。结果与结论:质量方针的贯彻与GMP实施进行充分的衔接,能使得这两个方面都能得到提高。

Objective： to discuss the means of linking GMP with the quality management policy in pharmaceutical enterprises. Method： based on the quality management principles and the requirements of GMP, to analyze the possibility and necessity of linking GMP with quality policy. Result and conclusion： to link the realization of GMP with the execution of quality policy will result in the enhancements in both sides.