| 葛渊源,陈桂良.英国2018年GMP检查缺陷对中国GMP实施的启示[J].中国药事,2020,34(8):901-908 |
| 英国2018年GMP检查缺陷对中国GMP实施的启示 |
| Implications of the UK's 2018 GMP Inspection Deficiencies for Chinese GMP |
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| DOI：10.16153/j.1002-7777.2020.08.008 |
| 中文关键词: 国家药品监督管理局 英国药品和保健品管理局 质量体系 符合性 有效性 数据可靠性 |
| 英文关键词: NMPA MHRA quality management system compliance effectiveness data reliability |
| 基金项目:上海市科学技术委员会软科学研究项目：药品上市许可持有人制度下的长三角区域协作药品监管制度与策略研究(编号 19692106300) |
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| 中文摘要: |
| 目的：通过对比国内外检查缺陷及其变化趋势，以获得对中国GMP实施的建议。方法：对比英国、中国及上海地区药品GMP检查缺陷，分析GMP检查的发展趋势，阐述对国内药品监管和企业管理的启示。结果与结论：对政府监管和企业管理的启示：一是检查重点由“检验”回归到“体系”；二是由关注“有没有”(符合性)到“有没有效”(有效性)；三是确保落实企业主体责任、完善自检管理体系；四是持续关注数据可靠性。 |
| 英文摘要: |
| Objective: This paper compares the deficiencies and their changing trends at home and abroad in order to get suggestions on the implementation of GMP in China. Methods: the deficiencies of drug GMP inspection in MHRA, NMPA and Shanghai district were compared, the development trend of GMP inspection was analyzed, and the enlightenment to domestic drug supervision and enterprise management was expounded. Results and Conclusion: Implications for governmental regulation and pharmaceutical management: first, restore the focus of inspection from "inspection" to "system"; second, effectiveness should be focused on instead of compliance; third, to ensure the implementation of the main responsibility of drug manufacturers and improve the self-inspection management system; fourth, to continue to focus on data reliability. |
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