药品生产过程中偏差的分类研究

发布时间：2018-05-15 11:30

本文选题：药品生产 + 偏差　；参考：《中国药房》2015年19期

【摘要】：目的:研究药品生产过程中偏差的分类。方法:从显性偏差和隐性偏差两个角度,结合风险管理理论,借助不同的风险管理工具对偏差进行风险评估,以界定偏差的严重程度,并采用不同的方法进行处理。结果与结论:根据实际管理过程中偏差的可识别性,可将偏差分为显性偏差和隐性偏差。对于显性偏差,可进行深、浅两个层次的分类;在进行浅层次分类后,判断是否可以明确偏差的发生原因及预估其后果,将偏差进一步分为简单偏差和复杂偏差;对于复杂偏差,可借助风险管理工具进行评估,界定偏差的严重程度。对于隐性偏差,需要事前预防,直接借助风险管理工具进行评估以界定偏差等级,为预防措施提供依据。在偏差的管理过程中,关键在于依靠科学的方法对偏差进行识别、分类和对影响等级进行划分。而结合风险管理理论,进行风险工具的选择和使用是解决该问题的有效途径。
[Abstract]:Objective: to study the classification of deviations in drug production. Methods: from two angles of dominant deviation and implicit deviation, combining with the theory of risk management, using different risk management tools to evaluate the risk of deviation, to define the severity of deviation, and to adopt different methods to deal with the deviation. Results & conclusion: according to the discernibility of deviation in actual management process, the deviation can be divided into explicit deviation and implicit deviation. For dominant deviation, it can be classified into two levels: deep and shallow; after the classification of shallow level, it can be judged whether the cause of the deviation can be determined and its consequences can be estimated, and the deviation can be further divided into simple deviation and complex deviation. For complex deviations, risk management tools can be used to evaluate the severity of deviations. For recessive deviation, it is necessary to prevent it in advance, and evaluate it directly by means of risk management tools to define the deviation grade and provide the basis for preventive measures. In the process of deviation management, the key lies in identifying, classifying and classifying the deviation by scientific methods. Combining the theory of risk management, choosing and using risk tools is an effective way to solve this problem.
【作者单位】：东南大学成贤学院;南京医药中等专业学校;上海市食品药品监督管理局;中国药科大学国际医药商学院;
【分类号】：R95

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