药品生产过程中偏差的分类研究  

Research on the Classification of Deviations in Drug Production

作　　者：于泳[1] 梅鑫[1] 方芳 崔文波[3] 沈启雯 

机构地区：[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

出　　处：《中国药房》2015年第19期2601-2604,共4页China Pharmacy

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。OBJECTIVE：To study the classification of deviation in drug production.METHODS：From the perspective of dominant and hidden deviation,combining with the theory of risk management,risk of deviation was evaluated with different risk management tools to define the severity of the deviation,and it was handled by different methods.RESULTS CONCLUSIONS：According 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 consequences 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 severity.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 method 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 

分 类 号：R95[医药卫生—药学]