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.