| 引用本文: | 朱渊,钱生稳.疫苗生产企业派驻检查工作机制的思考[J].中国现代应用药学,2022,39(13):1750-1754. |
| ZHU Yuan,QIAN Shengwen.Considerations on the Working Mechanism for Mill-based Quality Supervision of Vaccine Manufacturers[J].Chin J Mod Appl Pharm(中国现代应用药学),2022,39(13):1750-1754. |
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| 摘要: |
| 目的 建立疫苗生产企业派驻检查的日常工作机制。方法 通过疫苗检查制度梳理和派驻检查工作实践相结合的方法建立有效的派驻检查机制。结果 从派驻检查工作方法、派驻检查沟通机制2个方面建立了检查员在疫苗生产企业派驻检查的工作机制，并对检查工作中遇到的问题进行了讨论。结论 建立的派驻检查机制在实际检查工作中得到有效运用，为后续开展疫苗生产企业派驻检查工作提供参考。 |
| 关键词: 疫苗生产企业 派驻检查机制 沟通机制 |
| DOI：10.13748/j.cnki.issn1007-7693.2022.13.014 |
| 分类号:R951 |
| 基金项目: |
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| Considerations on the Working Mechanism for Mill-based Quality Supervision of Vaccine Manufacturers |
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ZHU Yuan1, QIAN Shengwen2
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1.Jiangsu Institute for Food and Drug Control, Nanjing 210019, China;2.Center for Inspection of JSMPA(Jiangsu Center for Vaccine Inspection), Nanjing 210019, China
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| Abstract: |
| OBJECTIVE To establish working mechanism for mill-based quality supervision of vaccine manufacturers. METHODS An effective inspection mechanism was established by combining the analysis of the vaccine inspection system and the working practice. RESULTS A working mechanism was established from two aspects:the working method and the communication mechanism of the mill-based quality supervision, and the problems encountered in the work were also discussed. CONCLUSION The established inspection mechanism has been effectively used in the actual inspection work, providing reference for the follow-up inspection work of vaccine manufacturers. |
| Key words: vaccine manufactures mill-based quality supervision mechanism communication mechanism |
