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食品药品监管系统微生物实验室质量控制探讨
引用本文:汤,茜等.食品药品监管系统微生物实验室质量控制探讨[J].中国药事,2014(4):358-360.
作者姓名:  茜等
作者单位:湖南省食品药品检验研究院,长沙410001
摘    要:目的随着检测范围的扩大和检测指标的增加,食品药品监管系统微生物实验室质量控制体系面临新的挑战。本文讨论微生物实验室质量控制关键问题,为食品药品监管系统微生物实验室管理提供参考。方法从实验室设施建设、试验人员操作培训、实验室质量管理3个方面,对微生物实验室质量控制关键点进行总结和分析。结果与结论加强设施建设,满足规范要求,合理整合资源,加强生物安全管理;注重人员操作培训及技术延伸软件建设;加强实验室质控关键点的管理,重视实验室比对和能力验证工作,是微生物实验室在新形势下提高综合质量控制水平的主要方面。

关 键 词:微生物实验室  质量控制  生物安全  实验室管理

Discussion on Quality Control of the Microbiology Laboratory in Food and Drug Supervision System
Tang Qian,Li Xiaoyan,Lin Hai and Hu Lin.Discussion on Quality Control of the Microbiology Laboratory in Food and Drug Supervision System[J].Chinese Pharmaceutical Affairs,2014(4):358-360.
Authors:Tang Qian  Li Xiaoyan  Lin Hai and Hu Lin
Institution:(Hunan Institute for Food and Drug Control, Changsha 410001)
Abstract:Objective Microbiology laboratories in food and drug supervision system are facing new challenges with the expansion of detection range and the increase of detection targets. This paper discusses the key problems on quality control in microbiology laboratories, in order to provide references for management on microbiology laboratory in food and drug supervision system. Methods The key points in quality control of the microbiology laboratories were summarized and analyzed from the following 3 aspects, laboratory facilities, testing personnel training, and laboratory quality management. Results and Conclusion The construction of facilities should be strengthened to meet specification requirements, resources be integrated reasonably to improve biological safety. Closer attention should be paid to personnel training and technical extension software development. Management on key links in quality control should be enhanced and greater importance should be attached to interlaboratory comparison and proficiency testing. The above are the main targets for the improvement of quality control of microbiology laboratories.
Keywords:microbiology laboratory  quality control  biological safety
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