浅谈药品微生物实验室质量管理
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篇名: 浅谈药品微生物实验室质量管理
TITLE:
摘要: 目的:加强药品微生物实验室质量管理,为相关检验机构提供参考。方法:从实验室文件管理、人员培训、质量控制、质量监督、过程控制、生物安全等方面入手,分析实验室质量管理要素,并提出有效措施以提高实验室质量管理水平。结果与结论:实验室应建立严格、规范、系统的实验室管理规章制度及质量文件、操作规程、工作指南等实现文件化管理;应开展多种形式的年度培训与考核计划,以建立一支专业检验队伍;加强内部(制订年度内部质量监督计划、举办质控活动、定期检查培养基的适用性)与外部(能力验证、实验室间比对)质量控制水平,并结合实际情况合理制订监督活动的内容和频次;此外,实验室还应强化检验过程控制,重视生物安全管理以提高实验室整体管理水平,将实验室质量风险降至最低。
ABSTRACT: OBJECTIVE: To strengthen quality management of drug microbiology laboratory and provide reference for relevant inspection institutions. METHODS: Taking measures from the laboratory document management, personnel training, quality control, quality supervision, process control and biological safety, the elements of laboratory quality management were analyzed, and effectively measures were put forward to improve the management level. RESULTS & CONCLUSIONS: The laboratory should establish strict, standardized, systematic laboratory management rules and regulations, quality documents, operating procedures, work guide, etc. to achieve documented management; develop various forms of annual training and assessment programs to construct a professional team; strengthen internal (developing an annual internal quality monitoring plan, conducting quality control activities, regularly checking the suitability of the medium) and external (capability testing, inter-laboratory comparison) management control level, and reasonably formulate the contents and frequency by combing with actual situation. Besides, the laboratory should strengthen inspection process control, attach great importance to the biological safety management to reduce the risk of laboratory quality to a minimum.
期刊: 2017年第28卷第7期
作者: 田冬梅,娄志红,张肖宁
AUTHORS: TIAN Dongmei,LOU Zhihong,ZHANG Xiaoning
关键字: 微生物实验室;质量管理;质量控制;生物安全
KEYWORDS: Microbiology laboratory; Quality management; Quality control; Biological safety
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