Validation of analytical methods: the international requirements

Analytical method is the most important part of chemical analysis, an action guide for the analyst and carrier of information about the metrological characteristics. To confirm the parameters and legitimize the methodology, Russian specialists traditionally use the procedure of metrological certification in accordance with GOST 8.563-2009. Validation of analytical procedures or analytical methods is a concept recently accepted in Russia and causes confusion in many domestic experts. However, this internationally accepted concept is actively used for long to assure the quality of chemical analysis. The European Community for Metrology in Analytical Chemistry (Eurachem) has developed a guide to validation of analytical methods «The Fitness for Purpose of Analytical Methods»; many articles have been published on this issue. This article is devoted to generalization of the similar features and individual differences in certification, validation and verification of the methods of chemical analysis. Metrological characteristics of the analytical methods are also considered. An emphasis is made on the procedure of estimating the uncertainty as the most important stage in the development and validation of the analytical method.

1. Prichard E., Barwick V. Quality Assurance in Analytical Chemistry. — Wiley, 2007. — 317 p.

2. Validation of analytical methods. Quantifying uncertainty in analytical measurements: Guide for laboratories / G. R. Nezhikhovsky, R. L. Kadis (eds.). — St. Petersburg: Professiya, 2016. — 312 p. [in Russian].

3. State Standard GOST R 8.563–2009. State System for ensuring the uniformity of measurements. Procedures of measurements. — Moscow: Standartinform, 2010. — 15 p. [in Russian].

4. Interstate Standard GOST ISO/IEC 17025–2009. General requirements for the competence of testing and calibration laboratories. — Moscow: Standartinform, 2018. — 27 p. [in Russian].

5. ISO/IEK 17025:2017. General requirements for the competence of testing and calibration laboratories. — ISO, 2017. — 38 p.

6. Magnusson B., Örnemark U. (eds). Eurachem Guide: The Fitness for Purpose of Analytical Methods — A Laboratory Guide to Method Validation and Related Topics. 2nd Edition. 2014. http://www.eurachem.org.

7. State Standard GOST R 52361–2018. Analytical assurance of the sample. Terms and Definitions. — Moscow: Standartinform, 2018. — 11 p. [in Russian].

8. Recommendation for Metrology R 50.2.060–2008. State System for ensuring the uniformity of measurements. Implementation of standardized methods of quantitative chemical analysis in the laboratory. Confirmation of compliance with the established requirements. — Moscow: Standardinform, 2009. — 11 p. [in Russian].

9. Ellison S. L. R., Williams A. (eds). Eurachem/CITAC Guide: Quantifying Uncertainty in Analytical Measurement. 3rd Edition. 2012. http://www.eurachem.org.

10. State Standard GOST R ISO 5725–2002. Accuracy (trueness and precision) of measurement methods and results. — Moscow: Standartinform, 2002 [in Russian].

11. Pharmacopoeia clause OFS.1.1.0012.15. Validation of analytical methods. www.pharmacopoeia.ru/ofs-1-1-012-15-validatsiya-analiticheskih-metodik [in Russian].