| 我国质量风险管理在GSP实施中的应用 |
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| 引用本文： | 施能进,罗文华,吴锦,邓在春.我国质量风险管理在GSP实施中的应用[J].中国药房,2012(41):3844-3846. |
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| 作者姓名： | 施能进 罗文华 吴锦 邓在春 |
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| 作者单位： | [1]浙江医药高等专科学校,浙江宁波315010 [2]宁波大学附属医院,浙江宁波315020 |
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| 基金项目： | 浙江医药高等专科学校校级科研项目ZPCSR2012013 |
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| 摘 要： | 目的:为药品经营企业在《药品经营质量管理规范》(GSP)实施中的质量风险管理提供参考。方法:采用风险评估、风险控制、风险审核的步骤和方法,运用风险排列和过滤工具,结合GSP实施中进货环节的实例对质量风险管理进行探析。结果与结论:药品经营企业需要树立正确的质量风险管理意识,运用恰当的管理工具,建立管理体系,以有效管理GSP实施中的质量风险。
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| 关 键 词： | 药品经营企业 质量风险管理 药品经营质量管理规范 应用 |
Application of Quality Risk Management in the Implementation of GSP in China |
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| SHI Neng-jin,LUO Wen-hua,WU JinZhejiang Pharmaceutical College,Zhejiang Ningbo,China . DENG Zai-chun.Application of Quality Risk Management in the Implementation of GSP in China[J].China Pharmacy,2012(41):3844-3846. |
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| Authors: | SHI Neng-jin LUO Wen-hua WU JinZhejiang Pharmaceutical College Zhejiang Ningbo China DENG Zai-chun |
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| Institution: | SHI Neng-jin, LUO Wen-hua, WU Jin(Zhejiang Pharmaceutical College, Zhejiang Ningbo 3 15010, China) . DENG Zai-chun(The Affiliated Hospital of Ningbo University, Zhejiang Ningbo 315020, China) |
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| Abstract: | OBJECTIVE： To provide reference for quality risk management in the implementation of GSP of drug trading enter- prises. METHODS： According to the step and methods of risk assessment and risk control as well as risk review, the tools of risk ranking and filtering were used to study quality risk management by the example of the implementation of GSP in drug purchase links. RESULTS ＆ CONCLUSIONS： The drug trading enterprises should have the right consciousness of quality risk management and use the reasonable tools of quality risk management to manage the quality risk during the implementation of GSP efficiently by building the system of quality risk management. |
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| Keywords: | Drug trading enterprises Quality risk management GSP Application |
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