| 黄宝斌,许明哲.欧洲官方药品质量控制实验室联盟的运行和管理[J].中国药事,2019,33(4):416-421 |
| 欧洲官方药品质量控制实验室联盟的运行和管理 |
| Operation and Management of European Official Medicines Control Laboratories Network |
| 投稿时间：2018-10-11 |
| DOI：10.16153/j.1002-7777.2019.04.011 |
| 中文关键词: 欧洲官方药品质量控制实验室联盟 欧洲药品健康管理局 运行和管理 |
| 英文关键词: European Official Medicines Control Laboratories Network European Directorate for the Quality of Medicines operation and management |
| 基金项目: |
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| 摘要点击次数: 1242 |
| 全文下载次数: 665 |
| 中文摘要: |
| 目的：介绍欧洲官方药品质量控制实验室联盟的日常运行和管理，为发挥我国各级药检所协同合作、资源互补提供制度和管理上的借鉴。方法：通过调研和查阅欧洲药品健康管理局发布的系列关于欧洲官方药品质量控制实验室联盟的章程、制度和技术指导原则，以及与欧洲药品质量控制实验室同行面对面的交流，全面详细了解欧洲官方药品质量控制实验室联盟的日常工作、运行机制和管理方式。结果与结论：在秘书处的统一协调领导下，欧洲官方药品质量控制实验室联盟有健全的管理体系，在实验室质量管理体系、能力验证、打击假药、上市后药品质量监督检验等方面发挥了重要的作用。 |
| 英文摘要: |
| Objective: To introduce the daily operation and manamgent of European Official Medicines Control Laboratories Network (OMCL) in order to provide institutional and managerial examples in collaboration and resource-sharing for the drug testing institutes of all levels in China. Methods: The routine work, operation system and the management method of the European OMCL were discussed in great details based on the survey and reviews of the charters, regulations and technical guidelines about European OMCL issued by European Directorate for the Quality of Medicines (EDQM), as well as face-to-face communications with staff of the European OMCL. Results and Conclusion: Under the unified coordination and leadership of the secretariat, Eurpoean OMCL has established a complete and sound management system which plays an important role in laboratory quality management systems, proficiency testing, fighting counterfeit drugs, and post-marketing drug quality supervision and testing. |
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