药品应急检验案例分析及应对策略  

On Drug Emergency Inspection Cases and Countermeasures

作　　者：车宝泉[1] 吴科春[1] 杨文良[1] Che Baoquan Wu Kechun Yang Wenliang(Beijing Institute for Drug Control, Beijing 102206, China)

机构地区：[1]北京市药品检验所,北京102206

出　　处：《中国药事》2016年第11期1086-1090,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:提升药品应急检验的响应速度和处置水平,为药品突发事件处置提供建议。方法:对我所承担的典型药品应急检验案例、稽查检验、储备样品检验进行分析,总结各项工作的经验及特点。结果:应急检验工作是对检验机构的技术能力、大规模样品检验能力、应急响应能力的全面考验,需制订适当的策略,积极应对。结论:通过预案制度及演练、健全组织机构、加强队伍建设,提高了应急响应能力;提出了流程设计、信息化建设、质量保证制度、保障检验工作的设想;通过总结及评价,提高了科研、应用快速检验技术,不断提高应急能力。Objective： To improve the speed of response and disposal of drug emergency inspection, and to provide recommendations for the disposal of drug emergencies. Methods： The typical cases of drug emergency inspection, reserve drugs inspection, the relational experiences in our institute were summarized and the characteristics were analyzed. Results： Drug emergency inspection is a test of technical capacity, inspective capacity and emergency response of inspection institution, so proper strategies should be formulated and countermeasures should be taken. Conclusion： Emergency response could be improved by system construction of institutional framework and training of staff; emergency inspection was carried out by rational process design, information construction and quality guarantee system; the emergency management, the ability of scientific research, as well as the application of fast detection technology would be significantly enhanced by reflection and evaluation.

关 键 词：药品检验 应急事件 应急响应 检验能力 应对策略 

分 类 号：R954[医药卫生—药学]