浅谈药品微生物实验室质量管理

发布时间：2018-03-18 16:16

本文选题：微生物实验室　切入点：质量管理　出处：《中国药房》2017年07期 　论文类型：期刊论文

【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 the quality management of pharmaceutical microbiology laboratory and provide reference for the relevant inspection organizations. Methods: from the aspects of laboratory document management, personnel training, quality control, quality supervision, process control, biosafety, etc. This paper analyzes the essential factors of laboratory quality management, and puts forward effective measures to improve the level of laboratory quality management. Results and conclusions: the laboratory should establish strict, standardized and systematic laboratory management rules and regulations, quality documents, operating procedures, etc. The work guide and so on realize the documented management; should carry out various forms of annual training and examination plan, in order to establish a professional inspection team; strengthen the internal (draw up the annual internal quality supervision plan, organize the quality control activity, Check regularly the suitability of the medium) and the quality control level of the external (capability verification, interlaboratory comparison), and reasonably determine the content and frequency of the monitoring activities in the light of the actual situation; in addition, the laboratory should also strengthen the control of the inspection process, Attention should be paid to biosafety management in order to improve the overall management level of the laboratory and minimize the risk of laboratory quality.
【作者单位】：黑龙江省食品药品检验检测所;
【分类号】：R954

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