| 安徽省药品批发企业新修订GSP实施中质量管理存在风险点研究 |
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| 引用本文： | 席永宽,张慧,黄世福,魏骅.安徽省药品批发企业新修订GSP实施中质量管理存在风险点研究[J].安徽科技学院学报,2017,31(1). |
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| 作者姓名： | 席永宽 张慧 黄世福 魏骅 |
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| 作者单位： | 安徽中医药大学,安徽 合肥,230001;安徽省食品药品审评认证中心,安徽 合肥,230001 |
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| 基金项目： | 安徽省高校省级科学研究重点项目，安徽省软科学项目 |
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| 摘 要： | 目的:从风险管理角度统计安徽省药品批发企业新修订GSP认证现场检查的缺陷项目,分析并查找质量管理风险点,并根据风险严重程度提出可行性应对风险的预案。方法:汇总安徽省2013年以来GSP认证现场检查缺陷项目,通过相关性与率的卡方检验,识别出共性风险与差异性风险,进行风险评估并采取相应风险预案。结果:2015年8月前后,药品批发企业认证通过率有差异,且存在共性与差异性缺陷项。结论:风险管理的理念和方法已经融入GSP的认证检查,通过风险控制,可以进一步规范药品流通行为。
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| 关 键 词： | 风险管理 药品流通 质量管理 GSP |
Research on the Risk of the Quality Management in theImplementation of the New Revised GSP in theWhole Sale Enterprises in Anhui Province |
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| XI Yong-kuan,ZHANG Hui,HUANG Shi-fu,WEI Hua.Research on the Risk of the Quality Management in theImplementation of the New Revised GSP in theWhole Sale Enterprises in Anhui Province[J].Journal of Anhui Science and Technology University,2017,31(1). |
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| Authors: | XI Yong-kuan ZHANG Hui HUANG Shi-fu WEI Hua |
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| Abstract: | Objective:Statistics of the defect projects of the new revised GSP certification on-site inspection of the pharmaceutical wholesale enterprises in Anhui Province from the perspective of risk management ,analyze and find out the risk point of quality management.Besides put forward the feasibility risk prevention measures according to the severity of the risk.Methods:Summary of the inspection defects GSP certification site since 2013 in Anhui province, identify common risk and different risk by correlation and rate of chi-square test ways, then risk assessment and take the corresponding risk plan.Results:Before and after August 2015, there are differences in the rate of adoption of the certification of drug wholesale enterprises, and there are defects in common and difference.Conclusion:The concept and method of risk management has been integrated into the GSP certification inspection, through risk control, can further regulate the behavior of drug circulation. |
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| Keywords: | Risk management Drug circulation Quality Assurance GSP |
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