| 广东省药品经营企业GSP认证现场检查缺陷项目分析 |
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| 引用本文： | 符光量,宋荣斌,张维安,李卓襄.广东省药品经营企业GSP认证现场检查缺陷项目分析[J].中国药事,2021(2):164-169. |
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| 作者姓名： | 符光量 宋荣斌 张维安 李卓襄 |
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| 作者单位： | 广东省药品监督管理局审评认证中心 |
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| 摘 要： | 目的:为药品监管部门GSP检查及药品经营企业完善药品经营质量管理提供技术参考。方法:通过对2018-2019年期间广东省药品批发企业及药品零售连锁企业总部的GSP认证现场检查发现的缺陷项目进行汇总分析,找出药品批发企业及药品零售连锁企业总部在药品质量管理中存在的问题。结果与结论:药品经营企业应该加强药品经营质量管理意识,加大对药品质量的管理力度,确保药品质量管理效果,为其持续发展夯实基础。
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| 关 键 词： | 药品经营企业 GSP认证 缺陷项目 分析 |
Analysis on Defects in Field Inspection for GSP Certification of Drug Handling Enterprises in Guangdong Province |
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| Fu Guangliang,Song Rongbin,Zhang Weian,Li Zhuoxiang.Analysis on Defects in Field Inspection for GSP Certification of Drug Handling Enterprises in Guangdong Province[J].Chinese Pharmaceutical Affairs,2021(2):164-169. |
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| Authors: | Fu Guangliang Song Rongbin Zhang Weian Li Zhuoxiang |
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| Institution: | (Center for Certification and Evaluation,Guangdong Drug Administration,Guangzhou 510080,China) |
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| Abstract: | Objective:To provide technical references for GSP inspection of the drug regulatory authorities and the improvement of drug management on drug trading quality of the drug handling enterprises.Methods:By summarizing and analyzing the defective items found during the on-site inspection for GSP certification of Guangdong drug wholesale enterprises and headquarters of the drug retail chain enterprises between the years of 2018 and 2019,the problems in drug quality management in these entities were disclosed.Results and Conclusion:Awarenesses of drug quality management should be aroused in the drug handling enterprises so as to make efforts to strengthen the drug quality management,ensure the effects of drug quality management and lay a solid foundation for its sustainable development. |
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| Keywords: | drug handling enterprises GSP certification defective items analysis |
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