| 郭林丰,康健,魏锡庚,屈浩鹏.疫苗派驻检查制度的实践与思考[J].中国药事,2023,(6):674-679 |
| 疫苗派驻检查制度的实践与思考 |
| Practice and Thinking of Vaccine on-site Inspection System |
| 投稿时间：2022-11-29 |
| DOI：10.16153/j.1002-7777.2023.06.006 |
| 中文关键词: 疫苗派驻检查 疫苗生产 药品监管 疫苗 药品检查 |
| 英文关键词: vaccine on-site inspection vaccine manufacture drug regulation vaccine drug inspection |
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| 中文摘要: |
| 目的：为完善疫苗派驻检查制度提供建议。方法：结合自身派驻检查工作实践，比较相关省级药监局疫苗派驻检查制度执行情况，分析其面临的问题，提出相应建议。结果与结论：该制度面临检查员终身追责压力大、专业能力有限、信息优势悖论等现实困境，建议明确制度定位，发挥“驻”的优势、 与GMP符合性检查制度错位发展、优化派驻方式和检查方案、紧盯风险信号。 |
| 英文摘要: |
| Objective: To provide suggestions for perfecting the vaccine on-site inspection system. Methods: Based on our own on-site inspection practice, this paper compares the implementation of the vaccine on-site inspection system of the relevant provincial medical administration, analyzes the problems it faced, and puts forward the corresponding suggestions. Results and Conclusion: The system faces many practical diffi culties, such as the great pressure of lifelong accountability, the limited professional ability of inspectors, and the paradox of information advantages. The paper suggests to clarify the system positioning, give full play to the advantages of "on-site", develop the GMP compliance inspection system in dislocation, optimize the on-site mode and inspection scheme, and focus on risk signals. |
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