摘要
随着食品药品质量标准的不断提高，检验工作自身的科学性、可靠性和有效性越来越倚重于仪器设备，目的是为了获得准确、可靠和稳定的数据及结果。由于分析仪器验证构成了产生质量数据的基础，因此分析仪器验证为实现上述目的提供了可行方式和重要保障。本文从分析仪器验证的4Q模型、3Q验证过程出发，论述了标准物质在色谱类分析仪器3Q验证过程中的作用、国内外应用研究现状以及验证过程中标准物质的选择原则，并针对目前的现状提出了今后的研究建议。
With the constant improvement of the food and drug quality standard, the scientific validity and reliability of detection work more and more relied on instruments and equipment, the purpose of which is to obtain accurate, reliable and stable data and results. Because analysis instrument verification forms the foundation of quality data, so the analysis instrument verification provides a feasible way and important guarantee for the achievement of above purpose. Based on the 4Q model and the progress of 3Q validation for analysis instrument, the role of standard material in 3Q validation for chromatographic analysis instrument, the research situation of different countries and the selection principle are discussed in this paper. According to the present situation, suggestions were put forward for the future research.
出处
《现代科学仪器》
2015年第6期46-49,共4页
Modern Scientific Instruments
基金
色谱类分析仪器3Q验证标准物质筛选与确认技术及方法研究（基金编号：562015G401101）
关键词
色谱
3Q验证
标准物质
Chromatography
3Q validation
Standard material
