我国与欧盟典型色谱分析仪器验证标准比对  

Comparative Study on Standards of Chromatographic Analysis Instrument Validation in China and EU

作　　者：魏利伟[1] 胡寻寻 李坤威[1] 张剑[1] 

机构地区：[1]中国标准化研究院

出　　处：《标准科学》2016年第5期68-71,共4页Standard Science

基　　金：2015年中央基本科研项目"气相色谱仪稳定性确认关键技术研究"(项目编号:222015Y-4006)资助

摘　　要：为了规范我国检验用仪器设备性能验证工作,加快国内检验机构在仪器设备质量控制和管理方面与国际先进实验室接轨,符合世界卫生组织药品预认证的相关要求,本文首先介绍了关于仪器验证的国际先进的4Q模型理论的基本概念和主要内容;其次,对中国和欧盟液相色谱验证标准进行了详细的梳理和比对,总结了两者之间的异同点;最后,结合我国实际情况,提出改进检测实验室仪器性能验证工作的合理化建议。To standardize qualification of testing instruments and equipment to help the domestic inspection agencies to adopt international standards in quality control and management and meet the prequalification requirements of World Health Organization. First of all, this paper introduces the basic concepts and main contents of the internationally advanced 4Q model theory which is about prequalification. Secondly, it compares and analyzes the prequalification standards of liquid chromatography in China and European Union in detail, and summarizes the similarities and difference between the two. At last, based on the real situation in China, it proposes reasonable suggestions to improve the prequalification of testing laboratories.

关 键 词：4Q模型 仪器设备性能验证 标准比对 

分 类 号：TH833[机械工程—仪器科学与技术]