摘要
药品生产企业的质量管理体系是保障药品质量的基础,对于防止用药事故、避免药品危害人们的身心健康有着重要作用。该文首先分析了药品生产企业在药品生产和质量管理过程中存在的问题,并针对这些问题提出了可行性的意见与建议,最后论述了2010版GMP在药品生产企业质量管理体系的实施,以期能对今后的药品生产企业的质量管理工作提供一定的指导。
The quality management system of pharmaceutical production enterprises is the basis of ensuring the quality of drugs and it is of great significance to prevent drug accidents and to avoid the hidden dangers caused by drug quality. In this paper, firstly the problems observed in the process of drug production and quality management are analyzed. Some feasible suggestions and recommendations are also provided. Then the implementation of GMP（2010 version） in the pharmaceutical production enterprise is discussed with a view to provide a certain guidance for the quality management of pharmaceutical production enterprises in the future.
出处
《中国卫生产业》
2016年第22期181-183,共3页
China Health Industry
关键词
药品生产企业
质量管理
GMP
Pharmaceutical production enterprise
Quality management
GMP
