| 山东省依企业申请药品生产质量管理规范符合性检查质量风险分析 |
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| 作者姓名： | 曹鸿雁 赵杰 柴发永 张杰 柏建学 |
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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： | 通过归纳法律法规对药品生产质量管理规范符合性检查的要求，统计分析2021年和2022年山东省承担的依企业申请开展的药品生产质量管理规范符合性检查情况发现，企业申请检查情形较为复杂，在质量管理、生产管理、确认与验证、数据管理等方面还存在质量风险。药品生产企业需关注在生产质量管理方面存在的薄弱环节，落实持有人主体责任，持续提升执行GMP的规范性和水平；监管部门需明确不同情形检查要点，科学高效开展现场检查。
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| 关 键 词： | 药品生产质量管理规范 符合性检查 检查情形 缺陷项目 质量风险 |
Quality risks analysis on the GMP compliance inspections requested by pharmaceutical enterprises in Shandong Province |
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| Authors: | CAO Hongyan ZHAO Jie CHAI Fayong ZHANG Jie BAI Jianxue |
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| Affiliation: | Shandong Center For Food and Drug Evaluation & Inspection,Jinan250014,China |
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| Abstract: | By summarizing the requirements of laws and regulations for GMP compliance inspections, and statistically analyzing the various situations of GMP compliance inspections requested by pharmaceutical enterprises in Shandong province in 2021 and 2022, we find that the requests are relatively complex, and there are quality risks in quality management, production management, qualification and validation, data management, and other aspects. Pharmaceutical enterprises should pay much attention to the weaknesses in the quality management, fulfill their own duties as MAH holders, and continuously improve the GMP compliance level; Regulatory authorities should clarify key inspection points for different GMP compliance requests, and conduct on-site inspections scientifically and efficiently. |
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