| 2020—2021年山东省药品经营许可变更检查缺陷项目分析 |
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| 引用本文： | 尚京迎,张娇. 2020—2021年山东省药品经营许可变更检查缺陷项目分析[J]. 药学研究, 2023, 42(2): 139-141 |
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| 作者姓名： | 尚京迎 张娇 |
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| 作者单位： | 山东省食品药品审评查验中心，山东 济南 250014 |
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| 摘 要： | 为防控药品批发企业的经营质量安全风险，本文对2020—2021年山东省药品批发企业变更检查缺陷项目进行数据统计，分析了药品批发企业的变更类型和现场检查缺陷项目，探讨了药品批发企业存在的经营质量管理问题，并对山东省药品批发企业的管理提出了合理化、专业性的对策和建议。
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| 关 键 词： | 药品批发企业 变更检查 缺陷项目 |
Analysis of Defective Items in Pharmaceutical Wholesale Enterprises Modification Inspection in Shandong Province |
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| SHANG Jingying,ZHANG Jiao. Analysis of Defective Items in Pharmaceutical Wholesale Enterprises Modification Inspection in Shandong Province[J]. Journal of Pharmaceutical Research, 2023, 42(2): 139-141 |
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| Authors: | SHANG Jingying ZHANG Jiao |
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| Affiliation: | Shandong Center for Food and Drug Evaluation & Inspection,Jinan 250014,China |
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| Abstract: | In order to prevent and control the operation quality and safety risks of pharmaceutical wholesale enterprises, the data was collected from the defective items in pharmaceutical wholesale enterprises modification inspection from 2020 to 2021, in order to analyze the modification type and the defective items which were found in the on-site inspection, expert interviews to analyze the current status and problems of the quality management of pharmaceutical wholesale enterprises in Shandong Province, and put forward rationalized and professional countermeasures and suggestions for pharmaceutical wholesale enterprises in Shandong Province. |
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| Keywords: | Pharmaceutical wholesale enterprises Modification inspection Defective items |
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