| 许广宁,邓雯姬,张庆芬,庞精聪,李书聪.新监管形势下广东省药品委托生产检查发现的问题与建议[J].中国药事,2024,38(7):752-756 |
| 新监管形势下广东省药品委托生产检查发现的问题与建议 |
| Issues and Suggestions of Pharmaceutical Contract Manufacturing Inspectionin Guangdong Province under the New Situation of Regulation |
| 投稿时间：2023-10-26 |
| DOI：10.16153/j.1002-7777.2024.07.004 |
| 中文关键词: 药品监管 药品委托生产 核心问题 现场检查 分析建议 |
| 英文关键词: drug regulation pharmaceutical contract manufacturing core issues inspection analyticalsuggestions |
| 基金项目: |
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| 中文摘要: |
| 目的：探索在新监管要求下药品委托生产许可（B证）持有人提高质量管理水平的策略。方法：通过整理往年药品委托生产B证检查发现的缺陷，分析B证企业存在缺陷的本质原因，结合新法规提出可行建议。结果与结论：对136条缺陷进行梳理，研究发现围绕在人员与机构、质量保障体系、文件与记录这三方面持有人主要存在责任缺位、沟通失位、执行断位的问题。建议B证持有人明晰双方责任、完善沟通制度、衔接执行规程，落实药品全生命周期的主体责任。 |
| 英文摘要: |
| Objective: To explore the strategy in improving the quality management level of holders ofpharmaceutical contract manufacturing (B certificate) under the new regulatory requirements. Methods: Bysorting out the found defects in the inspection of B certificate of pharmaceutical contract manufacturing inthe previous year, the essential reasons for the defects in Bcertificate enterprises were analyzed, and feasiblesuggestions were put forward in combination with the new regulations. Results and Conclusion: After combing136 defects, it was found that the problems of the holders mainly about three aspects (personnel and institution,quality assurance system, documents and records) were summarized into missing responsibility, communicationloss and execution loss. It is suggested that the B-certificate holders should clarify the responsibilities of bothparties, improve the communication system, link up the implementation procedures, and implement the mainresponsibility of the whole life cycle of drug. |
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