Trends in quality in the analytical laboratory. II. Analytical method validation and quality assurance

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.