Trends in quality in the analytical laboratory. II. Analytical method validation and quality assurance
Trends in quality in the analytical laboratory. II. Analytical method validation and quality assurance
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DOI：
10.1016/j.trac.2004.04.001
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发表时间：
2004-09-01
影响因子：
13.1
通讯作者：
Van Bockstaele, E
中科院分区：
文献类型：
--
作者：
Taverniers, I;De Loose, M;Van Bockstaele, E
国际公认，分析实验室必须进行验证。使用经验证的方法对于分析实验室显示其资格和能力非常重要。在分析质量的更新中，我们将分析方法学的验证置于更广泛的质量保证（QA）背景下。我们讨论了不同的验证方法，注意方法性能的不同特点。本文介绍了单实验室或内部验证、实验室间或协作研究、标准化、内部质量控制（IQC）、能力验证（PT）、认可以及分析质量保证（AQA）等概念，对分析方法验证和质量保证领域的相关信息进行了全面、及时的整理。它描述了QA框架中方法验证的不同方面。它为参与任何分析方法的任何人提供了洞察力和直接帮助，无论他们是学术研究人员还是工业部门。(C)2004 Elsevier Ltd.保留所有权利。
It is internationally recognized that validation is necessary in analytical laboratories. The use of validated methods is important for an analytical laboratory to show its qualification and competency. In this update on analytical quality, we place validation of analytical methodologies in the broader context of quality assurance (QA). We discuss different approaches to validation, giving attention to the different characteristics of method performance. We deal with the concepts of single-laboratory or in-house validation, inter-laboratory or collaborative study, standardization, internal quality control (IQC), proficiency testing (PT), accreditation and, finally, analytical QA (AQA).This article provides a good, complete, up-to-date collation of relevant information in the fields of analytical method validation and QA. It describes the different aspects of method validation in the framework of QA. It offers insight and direct help to anyone involved in any analytical methodologies, whether they are an academic researcher or in the industrial sector. (C) 2004 Elsevier Ltd. All rights reserved.