摘要
目的 通过汇总分析近年来出现和进行的多个药品应急检验典型案例,以便为药品安全突发事件的处置提供新思路与有效措施。方法 运用汇总分析法,研究典型突发事件的应急检验应对流程;运用流程分析法,研究药品应急检验的流程管理特点。结果 梳理典型应急检验案例流程,分析了案例的流程管理特点。结论 流程管理可以提高应急检验的工作效率,可以指导相关工作有序进行,进一步提升应急检验的管理水平。
Abstract
OBJECTIVE To provide new ideas and effective measures to deal with the drug incidents by analyzing and summarizing some typical drug emergency inspection cases, occurring in recent years. METHODS Firstly, the inspecting procedures of some typical drug incidents were analyzed, and the experiences by method of summary analysis were extracted. Secondly, the flowchart of every case investigation was drawed by method of flow analysis.RESULTS The processes of these typical emergency inspection cases were combed, and then the process management characteristics were analyzed.CONCLUSION It can improve the efficiency of emergency inspection and guide the related jobs in an orderly manner by implementing process management, and then further enhance the level of emergency inspection managements
关键词
药品检验 /
应急 /
流程管理
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Key words
drug inspection /
emergency /
process management
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高志峰,颜晓航,雷毅,杨化新*.
药品应急检验流程管理探讨[J]. 中国药学杂志, 2014, 49(21): 1957-1960 https://doi.org/10.11669/cpj.2014.21.021
GAO Zhi-feng, YAN Xiao-hang, LEI Yi,YANG Hua-xin*.
Discussion on the Process Management of Drug Emergency Inspection[J]. Chinese Pharmaceutical Journal, 2014, 49(21): 1957-1960 https://doi.org/10.11669/cpj.2014.21.021
中图分类号：
R954
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参考文献
[1] GAO Z F. Discussion on the reaction mechanism of drugincidents in China[J]. Chin J Pharmacovigilance (中国药物警戒),2013,10(4):207.[2] XIE Z J. Practice research on emergency testing investigation of the armillarisin A injection (I)[J]. Chin Pharm Aff(中国药事),2009,23(3): 243.[3] XIE Z J.Research on Drug Emergency Inspection Cases(药品质量应急检验案例研究)[M].Beijing: China Medical Science Press,2012:44-49.[4] GAO Z F.My opinion about how to establish an efficient system of approving inspection and additional testing methods[J]. Chin Pharm Aff(中国药事),2011,25(5):449-450.[5] Ch.P(2010) Vol II(中国药典2010年版二部)[S].2010: appendix I: 24-25.
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脚注
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基金
中国食品药品检定研究院学科带头人课题《科学检验精神研究》之《药品应急检验管理研究》(2012X1-12)
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