| 失效模式与影响分析法评价药品GMP认证缺陷改正效果的探讨 |
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| 引用本文： | 冉大强,李泮海,臧恒昌.失效模式与影响分析法评价药品GMP认证缺陷改正效果的探讨[J].食品与药品,2012(3):117-119. |
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| 作者姓名： | 冉大强 李泮海 臧恒昌 |
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| 作者单位： | 山东大学药学院;山东省药品审评认证中心 |
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| 摘 要： | 目的探索质量风险管理在药品GMP认证中的应用,使用风险管理工具,指导药品GMP认证技术审评工作。方法用风险管理工具失效模式与影响分析(FMEA)法,评价企业缺陷项目改正的效果。结果和讨论使用FMEA评价整改报告,使药品GMP认证技术审查更系统化、更具科学性。
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| 关 键 词： | 失效模式与影响分析 药品GMP认证 改正效果评价 |
Discussion on Corrective Effect of GMP Inspection Deficiency Items with FMEA Method |
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| RAN Da-qiang,LI Pan-hai,ZANG Heng-chang.Discussion on Corrective Effect of GMP Inspection Deficiency Items with FMEA Method[J].Food and Drug,2012(3):117-119. |
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| Authors: | RAN Da-qiang LI Pan-hai ZANG Heng-chang |
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| Affiliation: | 1 (1.School of Pharmaceutical Sciences,Shandong University,Jinan 250012,China;2.Shandong Center for Drug Evaluation and Certification,Jinan 250013,China) |
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| Abstract: | Objective To explore the application of Quality Risk Management in pharmaceutical GMP certification, and instruct the technical evaluation of GMP inspection with the tool of risk management.Methods The corrective effect of the inspected deficiency items was evaluated with FMEA(Failure Mode and Effects Analysis) as the risk management tool.Result and Discussion With FMEA report,the GMP technical evaluation will be more systematic and more scientific. |
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| Keywords: | FMEA pharmaceutical GMP certification evaluation on corrective effect |
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