GLP实验室中试剂管理的关注点探讨

Discussion on the focus of reagent management in GLP laboratory

目的探讨GLP实验室中试剂管理的关注点.方法梳理对应的法律、法规及相关文件,总结在GLP符合性检查中发现的问题进行关注点的讨论.结果GLP实验室的试剂根据用途可分为化学试剂和临床检验用试剂.化学试剂需要根据法律法规或试剂说明书的要求进行分类、存放和使用,特殊化学品需要有购买、贮存和使用的过程记录,重要试剂应制定质量控制的标准操作规程.临床检验用试剂,需要特别关注试剂的质量控制和有效期管理,通过试验的积累形成本实验室的临床检验试剂的背景数据和质量控图.试剂废弃的控制包括收集、储存和移交处理,保存处理单位的资质以及储存和移交的过程记录.结论GLP实验室应制定试剂的使用控制程序,包括分类、储存环境、试剂信息管理和废弃试剂的处理等,需要关注实验室的管理规定与国家法律法规的符合性.

Objective To discuss the concerns of reagent management in GLP laboratories.Methods Sort out the corresponding laws,regulations and related documents,summarize the problems found in the GLP compliance inspection and discuss the concerns.Resu Its The reagents in the GLP laboratory can be divided into chemical reagents and clinical test reagents according to their uses.Chemical reagents need to be classified,stored and used in accordance with the requirements of laws and regulations or reagent instructions.Special chemicals need to have process records of purchase,storage and use.Important reagents should develop standard operating procedures for quality control.Reagents for clinical testing need to pay special attention to lhe quality control and validity management of the reagents.Through the accumulation of experiments,the background data and quality control charts of the clinical testing reagents in our laboratory are formed.The control of reagent waste includes colleclion,storage and handover treatment,preservation of the qualifications of the processing unit,and storage and handover process records.Conelusion GLP laboratories should develop reagent use control procedures,including classification,storage environment,reagent information management,and disposal of waste reagents etc.,and need to pay attention to the compliance of laboratory management regulations with national laws and regulations.