摘要
目的:促进我国药品生产偏差管理水平提高,更好地保证药品质量。方法:通过调研辽宁省24家药品生产企业,一定程度上掌握我国药品生产企业药品生产偏差管理现状,进而分析其中存在的问题,并对比国外情况提出完善的建议。结果与结论:我国药品生产偏差管理与国外的有关规范要求存在较大差距。为此,建议从提高偏差管理认识、加强偏差管理培训、建立科学的偏差管理程序、建立全面的纠正预防措施等方面完善我国的药品生产偏差管理。
OBJECTIVE：To improve the management of pharmaceutical manufacturing deviations in China,and to ensure drug quality.METHODS：Through conducting research in 24 pharmaceutical manufacturers,the status quo of pharmaceutical manufacturing deviation management was investigated and the relevant problems were analyzed.Improving suggestions were put forward according to the comparison of domestic and foreign management requirements.RESULTSCONCLUSIONS：There are still a big gap between the management of pharmaceutical manufacturing deviations in China and foreign standard.The management of pharmaceutical manufacturing deviations should be improved in respect of improving deviation cognition,strengthening the relative training,establishing effective program and completing the corrective and preventive measures.
出处
《中国药房》
CAS
CSCD
北大核心
2011年第1期1-4,共4页
China Pharmacy
关键词
药品
生产
偏差管理
调研
Drug
Manufacturing
Deviation management
Research
