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Method validation

Background

Method validation - experimental demonstration of the suitability of an analytical method - is an important requirement in the practice of analytical measurement. Millions of tests, measurements and examinations are made every day in thousands of laboratories around the world. There are innumerable reasons underpinning them, for example: as a way of valuing goods for trade purposes; supporting healthcare; checking the quality of drinking water, food and feed; analysing the elemental composition of an alloy to confirm its suitability for use in aircraft construction; forensic analysis of body fluids in criminal investigations. Virtually every aspect of society is supported in some way by analytical work. The cost of carrying out these measurements is high and additional costs may arise from decisions made on the basis of the results. For example, tests showing food to be unfit for consumption may result in compensation claims; tests confirming the presence of banned drugs could result in fines, imprisonment or even, in some countries, execution. Clearly it is important to make a correct measurement and be able to show that the result is correct. Method Validation is the process of demonstrating that a particular analytical measurement procedure is suitable for its intended purpose, by determining key performance characteristics and comparing with requirements.

Resources

Eurachem provides a range of resources relevant to understanding, planning, performing and evaluating method validation. The main focus is on in-house (single laboratory) validation.

  • The guide “The Fitness for Purpose of Analytical Methods: A Laboratory Guide to Method Validation and Related Topics” (2nd ed. 2014) is the principal Eurachem Guide on validation. The guide is available in multiple languages and includes information on:
    • The concept of method validation;
    • The background and rationale for method validation;
    • How a method validation study should be performed and how much should be done (validation/verification);
    • A thorough explanation of the various validation parameters (performance characteristics);
    • Follow-up on the validation study (reporting, use of performance data in Internal Quality Control);
    • Documentation of analytical methods.
  • In cooperation with the Eurachem Education Training Working Group (ETWG), the MVWG maintains the Method Validation section of the Eurachem Reading List of useful publications. The Reading List also contains references to many other topics in analytical quality assurance.