深入实施药品GMP管理贵在观念更新

目的探索药品生产领域深入贯彻药品GMP,确保生产环节药品质量的途径。方法通过对药品生产企业实施GMP管理状况的调查,归纳分析存在的问题及产生问题的原因。结果与结论药品生产领域深入贯彻GMP,必须进一步解放思想,引导企业树立以人为本的观念、药品质量是生产出来的观念、过程控制的观念、文件的权威性观念;同时,监管部门也要树立行政指导的监管理念。

Reformation of Concept is Essential to Better Implementation of GMP

Objective Explore the implementation of GMP in pharmaceutical production to ensure the quality of medicines. Methods Through the survey of implementation of GMP in pharmaceutical manufacturing enterprises,summary analysis of current management in the implementation of GMP was carried out. Results and Conclusion We must further reform our concept about GMP,guide enterprises to establish a series of new concept,such as a man-oriented concept,and the concept that the quality of medicines is determined by the manufacturing process,and the concept of process control,the concept of documentary authority. The supervision department of the government should establish a concept of administrative guidance.