中国药房Issue(19)：2601-2603,2604,4.DOI:10.6039/j.issn.1001-0408.2015.19.03
药品生产过程中偏差的分类研究
Research on the Classification of Deviations in Drug Production
于泳 1梅鑫 1方芳 2崔文波 3沈启雯4
作者信息
- 1. 东南大学成贤学院，南京 210088
- 2. 南京医药中等专业学校，南京 211100
- 3. 上海市食品药品监督管理局，上海 200439
- 4. 中国药科大学国际医药商学院，南京 210009
- 折叠
摘要
Abstract
OBJECTIVE:To study the classification of deviation in drug production. METHODS:From the perspective of dom-inant and hidden deviation,combining with the theory of risk management,risk of deviation was evaluated with different risk man-agement tools to define the severity of the deviation,and it was handled by different methods. RESULTS & CONCLUSIONS:Ac-cording to the identifiability of deviation in actual management,the deviation was divided into dominance and hidden deviation. The dominant deviation can be divided into deep and shallow level. Whether the causes of deviation could be cleared and the conse-quences could be estimates were judged after the shallow level classification,and the deviation was further divided into simple and complex deviation. As for deviation complex,it could be evaluated with the tools of risk management to define the deviation severi-ty. As for hidden deviation,it needed beforehand preventing with the tools of risk management directly to define deviation levels and provide reference for preventive measures. In the process of deviation management,key point is to relay on the scientific meth-od to identify and classify deviation,and divide the influence levels. Combining the theory of risk management to select and use risk tools is the effective way to solve the problem.关键词
药品生产/偏差/分类/风险管理工具Key words
Drug production/Deviation/Classification/Risk management tools分类
医药卫生引用本文复制引用
于泳,梅鑫,方芳,崔文波,沈启雯..药品生产过程中偏差的分类研究[J].中国药房,2015,(19):2601-2603,2604,4.
