| 王晔,陈晓燕,钱正旭.疫苗生产企业的管理评审和自检的区别与联系[J].中国药事,2024,38(3):320-325 |
| 疫苗生产企业的管理评审和自检的区别与联系 |
| The Difference and Connections between Management Review and Selfinspectionof Vaccine Manufacturers |
| 投稿时间：2023-08-20 |
| DOI：10.16153/j.1002-7777.2024.03.011 |
| 中文关键词: 疫苗 管理评审 自检 质量管理体系 体系建设 |
| 英文关键词: vaccine management review self-inspection quality management system system construction |
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| 中文摘要: |
| 目的：识别、探究疫苗生产企业质量管理工作中的管理评审和自检的区别与联系，指导企业在生产经营管理过程中有效运用管理评审和自检这两种措施，达到提升质量管理水平的目的。方法：用差距分析方法对照ISO 9001和《药品生产质量管理规范》（2010年修订），分析疫苗生产企业的管理评审和自检的区别与联系。结果：疫苗生产企业的管理评审和自检在审核主体、审核要素与依据、组织实施人员、报告内容和输出程度方面存在差异，同时二者都是企业质量管理的重要内容，相互促进、互为补充。结论：管理评审和自检是企业自我监督、自我完善的重要举措，有效将二者结合起来才能多层级、全方位地提升企业质量管理水平。 |
| 英文摘要: |
| Objective: To achieve the purpose of improving the quality management level by identifyingand exploring the differences and connections between management review and self-inspection in the qualitymanagement of vaccine manufacturers, and guide manufacturers to eff ectively implement management review andself-inspection in production and operation process. Methods: Compared with ISO 9001 and Good Manufacturing Practice (revised in 2010), the gap analysis method was used to analyze the diff erences and connections betweenmanagement review and self-inspection of vaccine manufacturers. Results: There were diff erences between themanagement review and self-inspection of vaccine manufacturers in terms of audit subjects, audit elements andbasis, organization and implementation personnel, report content and output content, but at the same time, bothwere important aspects of manufacturers quality management, which should be promoted and complementedeach other. Conclusion: Management review and self-inspection are important measures for manufacturers selfsupervisionor self-improvement. By eff ectively combining the two in management activities, manufacturers canenhance the level of quality management in a multi-level and in all aspects. |
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