运用5M1E提升GLP质量管理水平  

Improving Quality Management Level of GLP with 5M1E

作　　者：冯群 姚景春 柏学东 李进启 张贵民 Feng Qun;Yao Jingchun;Bai Xuedong;Li Jinqi;Zhang Guimin(Lunan Pharmaceutical Group Co.Ltd.,Linyi 276006,China;Shandong New Time Pharmaceutical Co.Ltd.,Linyi 273400,China;Lunan Hope Pharmaceutical Co.Ltd.,Linyi 276006,China)

机构地区：[1]鲁南制药集团股份有限公司,临沂276006 [2]山东新时代药业有限公司,临沂273400 [3]鲁南厚普制药有限公司,临沂276006

出　　处：《中国药事》2020年第5期564-569,共6页Chinese Pharmaceutical Affairs

摘　　要：目的:"人、机、料、法、测、环"六大要素又称为"5M1E",是分析质量问题最常用的模型。本文运用"5M1E"模型,探讨提升我国药物非临床研究机构质量管理水平的措施。方法:运用"5M1E"模型,分析影响GLP质量管理水平的主要因素,探讨有效的控制措施。结果与结论:人是GLP的主体,通过培训确保关键人员对合规性的认识;机是GLP的基本工具,建立一系列的措施,确保工具可用性和适用性;料作为数据的载体,应具有可靠性和稳定性;法是保证试验质量和进度的重要条件;测是确保仪器准确、操作准确的关键环节;环作为GLP运行的载体,影响实验系统的稳定性和专题试验的顺利。药物研发、生产的监管系统越来越完善,GLP机构的人员必须提高质量管理意识和水平。通过在GLP中应用"5M1E"模型,实现培养人才队伍、降本增效、提高GLP质量管理水平的目标。Objective: The six factors of "man/manpower, machine, material, method, measurement and environment", as known as "5M1E", consist the most frequently-used analyzing model for quality problems. This article adopted this model to discuss the control measures in improving quality management level in GLP(good laboratory practice) facilities in China. Methods: "5M1E" model was used to analyze the main factors that affect the quality management level of GLP and to explore the effective control measures. Results and Conclusion: Man is the body of GLP and trainings are necessary for key personnel to deepen the understanding of compliance. Machine is the basic tool of GLP and a series of measures are established to ensure the availability and applicability of equipment and instruments. Materials, as the carrier of data, should be dealt with to ensure their reliability and stability. It is important for methods to ensure the quality and schedule of experimental projects and measurements are pivotal for accuracy of machine and operation. Environment is the carrier of GLP and it will influence the stability of material and schedule of experimental projects as well. With the improvement of regulatory in drug research, development and manufacturing, the awareness and levels of quality management should be enhanced. An idea will be provided by "5M1E" model for cultivating talents, reducing the cost, increasing economic results, developing and improving GLP quality management levels.

关 键 词：药物非临床研究质量管理规范 质量管理 5M1E 

分 类 号：R95[医药卫生—药学]