A practical guide to analytical method validation, including measurement uncertainty and accuracy profiles

The objective of analytical method validation is to ensure that every future measurement in routine analysis will be close enough to the unknown true value for the content of the analyte in the sample. Classical approaches to validation only check performance against reference values, but this does not reflect the needs of consumers. A holistic approach to validation also takes into account the expected proportion of acceptable results lying inside predefined acceptability intervals.In this article, we give a detailed step-by-step guide to analytical method validation, considering the most relevant procedures for checking the quality parameters of analytical methods. Using a holistic approach, we also explain the estimation of measurement uncertainty and accuracy profiles, which we discuss in terms of accreditation requirements and predefined acceptability limits.