关于GLP实验室建设的软硬件要求  

The request of software and hardware to establish the GLP laboratory

作　　者：杨正萼[1] 

机构地区：[1]首都医科大学临床检验中心,北京100054

出　　处：《医疗设备信息》2005年第3期41-42,30,共3页Information of Medical Equipment

摘　　要：通过对GLP的产生背景和我国的现状以及今后GLP发展趋势的分析 ,阐明了建立GLP实验室的重要性和具体实施中的软硬件要求。软件建设中人员素质是关键 ,标准操作规程 (SOP)的制定对实施GLP至关重要 ,管理监督是实施GLP的有力保证。硬件建设中完整配套的实验设施和自动化仪器设备是毒性评价工作顺利进行和高质量完成的重要保障。实施GLP可以提高药品非临床安全性评价研究的质量 ,减少人为误差 ,得到可信性高的实验数据 ,以保障人民用药安全。To analyze background,current state and development direction of the GLP,this article make clearly the esˉsentiality of the GLP laboratory construct and the request of software and hardware in material implement.First the key point is the ability of software staff.The SOP establishment is very important to carry out the GLP,the administer monitor also assures the GLP to be carried out effectively.Second the complete experiment establishment and auto-instrument equipment are important guarantee to perform successfully and to fulfill qualitatively toxicity evaluate in hardware.Finally the GLP to be carried out may improve medicine quality in non-security evaluation study,reduce man-made error,obtain experiment data of high reliability and ensure medicine security.

关 键 词：GLP 软硬件 SOP 

分 类 号：R-33[医药卫生]