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| 药品上市许可持有人对受托企业生产现场全过程监督存在问题及建议 |
| Issues and Suggestions regarding the Full Process Production Site Supervision of the Entrusted Enterprise by Marketing Authorization Holder |
| 投稿时间：2024-06-05 修订日期：2024-08-13 |
| DOI： |
| 中文关键词: 药品上市许可持有人 受托企业 全过程生产监督 主要问题 分析建议 |
| 英文关键词: Marketing Authorization Holder entrusted enterprise the full process production site supervision Main issues Analysis suggestions |
| 基金项目: |
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| 中文摘要: |
| 目的：探索在新形势下药品上市许可持有人（MAH）对受托企业生产现场全过程监督的应对策略。方法：通过梳理广东省药品B类生产许可证（以下简称B证）持有人委托省外企业生产的延伸检查情况，深入探讨当前MAH在受托企业生产现场全过程监督中存在的问题及原因，并根据药品生产质量管理和关于加强上市后持有人管理的相关规定 提出了相应的改进建议。结果：对受托生产延伸检查状况进行整理，发现MAH存在关键人员配置、全过程监督理解、生产风险研判3个方面存在问题，具体表现为人员工作经验不丰富、全过程监督方式不严谨、生产风险研判不全面。结论：建议B证持有人聚焦关键人员压实主体责任、完善管理流程规范监督行为、强化风险研判排查安全隐患，确保关键人员的数量资质与生产规模匹配、形成全过程生产的闭环质量管理、开展全方位精准化风险研判，牢固树立药品质量安全意识。 |
| 英文摘要: |
| Objective: Explore the coping strategy to the full process production site supervision of the entrusted enterprise by Marketing Authorization Holder（MAH）under the new situations. Methods: By summarizing the extension inspection of entrusting production enterprises outside the province by pharmaceutical contract manufacture (B-certificate)MAH on Guangdong Province，and analyzing the problems and reasons for the full process production site supervision of the entrusted enterprise by MAH, this paper put forward corresponding improvement suggestions based on Good Manufacturing Practice of Medical Products and the regulations on strengthening the management of post-marketing holders. Results: After combing the status of entrusted production extension inspections, it was found that three aspects problems of holder about key personnel configuration, understanding of the entire process supervision and production risk assessment，which are manifested in the lack of rich work experience of personnel, the lack of rigorous supervision methods throughout the entire process, and the incomplete assessment of production risks. Conclusions：The B-certificate MAH should focus on key personnel to fulfill their main responsibilities, improve management processes to standardize supervision behavior, strengthen risk assessment to identify safety hazards, so as to ensure the number and qualifications of key personnel match the production scale, form a closed-loop quality management system for the entire production process，Carry out comprehensive and precise risk assessment, and firmly establish awareness of drug quality and safety. |
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