| 2017~2019年辽宁省药品GMP检查质量控制缺陷分析 |
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| 引用本文： | 王晓,高永宝,王璐,马辉,魏晶.2017~2019年辽宁省药品GMP检查质量控制缺陷分析[J].中国药学杂志,2021,55(23):1932-1934. |
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| 作者姓名： | 王晓 高永宝 王璐 马辉 魏晶 |
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| 作者单位： | 辽宁省检验检测认证中心, 沈阳 110016 |
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| 摘 要： | 目的 对近年辽宁省药品认证检查过程中发现的质量控制相关缺陷进行汇总和分析,为监管和行业提供参考。方法 对辽宁省2017~2019年认证的197家次企业的质量控制缺陷进行汇总,对高频缺陷进行归纳和分析。结果与结论 药品上市许可持有人或受托方应在人员培训、计量校验、实验室管理方面加强力度,控制检验环节质量风险。
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| 关 键 词： | 药品生产质量管理规范 药品检验 缺陷分析 |
| 收稿时间： | 2020-07-31 |
Quality Control Deficiencies Analysis of Drug GMP Inspection of 2017-2019 in Liaoning Province |
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| WANG Xiao,GAO Yong-bao,WANG Lu,MA Hui,WEI Jing.Quality Control Deficiencies Analysis of Drug GMP Inspection of 2017-2019 in Liaoning Province[J].Chinese Pharmaceutical Journal,2021,55(23):1932-1934. |
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| Authors: | WANG Xiao GAO Yong-bao WANG Lu MA Hui WEI Jing |
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| Institution: | Liaoning Inspection, Examination & Certification Centre, Shenyang 110016, China |
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| Abstract: | OBJECTIVE To summarize and analyze the deficiencies of quality control found in the process of drug certification inspection in Liaoning province in recent years, so as to provide reference for supervision and industry. METHODS The quality control deficiencies of 197 times certified by Liaoning province from 2017 to 2019 were summarized, and the high-frequency deficiencies were summarized and analyzed. RESULTS AND CONCLUSION The system of permit-holders for the sale of pharmaceuticals(MAH) or the consignee should strengthen the training of personnel, measurement and verification, laboratory management, to control the risk in quality control. |
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