| 2016-2020年云南省药包材抽验与质量初步分析 |
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| 引用本文： | 马晓彬,孙磊,李生法,刘丹丹.2016-2020年云南省药包材抽验与质量初步分析[J].中国药事,2022,36(7):785-791. |
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| 作者姓名： | 马晓彬 孙磊 李生法 刘丹丹 |
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| 作者单位： | 云南省医疗器械检验研究院,昆明 650106;昆明医科大学药学院暨云南省天然药物药理重点实验室,昆明 650500 |
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| 摘 要： | 目的：分析2016-2020年云南省药品包装材料产品质量监督抽验情况，掌握辖区内药包材的质量状况，为未来监管工作提供参考。方法：对云南省2016-2020年药包材监督抽验数据进行分析。结果与结论：目前药包材质量总体稳定。监督抽验可以有效督促生产企业加强药包材质量控制，特别是药包材关联审评审批制度实施后，更能有效防控质量风险。
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| 关 键 词： | 药包材 质量监督 质量控制 抽验 分析 |
Analysis to Sampling Inspection and Its Quality of Pharmaceutical Packaging Materials in Yunnan Province from 2016 to 2020 |
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| Ma Xiaobin,Sun Lei,Li Shengf,Liu Dandan.Analysis to Sampling Inspection and Its Quality of Pharmaceutical Packaging Materials in Yunnan Province from 2016 to 2020[J].Chinese Pharmaceutical Affairs,2022,36(7):785-791. |
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| Authors: | Ma Xiaobin Sun Lei Li Shengf Liu Dandan |
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| Affiliation: | Yunnan Institute of Medical Device Testing, Kunming 650106 , China;School of Pharmaceutical Science, Yunnan Key Laboratory of Pharmacology for Natural Products, Kunming Medical University, Kunming 650500 , China |
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| Abstract: | Objective: To analyze the product quality supervision and sampling inspection of drug packaging materials in Yunnan province from 2016 to 2020 and master the quality status of drug packaging materials within the jurisdiction in order to provide references for the next supervision. Methods: The supervision and sampling inspection data of drug packaging materials in Yunnan province from 2016 to 2020 were analyzed. Results: The quality of drug packaging materials is generally stable at present. Conclusion: Supervision and sampling inspection can effectively urge manufacturers to strengthen the quality control of drug packaging materials, especially after the implementation of DMF system for pharmaceutical packaging materials. It can more eff ectively prevent and control quality risks. |
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