The Eurachem reading list

7. Validation of analytical methods

Standards

  • ASTM E1169 – 21. Standard practice for conducting ruggedness tests. ASTM International (www.astm.org)
  • CEN/TS 16800:2020 Guideline for the validation of physico-chemical analytical methods (https://standards.cencenelec.eu/)
  • ISO 5725-1:2023. Accuracy (trueness and precision) of measurement methods and results – Part 1: General principles and definitions (iso.org)
  • ISO 5725-2:2019. Accuracy (trueness and precision) of measurement methods and results – Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method (www.iso.org)
  • ISO 5725-3:2023. Accuracy (trueness and precision) of measurement methods and results – Part 3: Intermediate measures of the precision of a standard measurement method (and Corrigendum 1:2001) (www.iso.org)
  • ISO 5725-4:2020. Accuracy (trueness and precision) of measurement methods and results – Part 4: Basic methods for the determination of the trueness of a standard measurement method (www.iso.org)
  • ISO 5725-5:1998. Accuracy (trueness and precision) of measurement methods and results – Part 5: Alternative methods for the determination of the precision of a standard measurement method (and Corrigendum 1: 2005) (www.iso.org)
  • ISO 5725-6:1994. Accuracy (trueness and precision) of measurement methods and results – Part 6: Use in practice of accuracy values (and Corrigendum 1: 2001) (www.iso.org)
  • ISO 8466-1:2021. Water quality — Calibration and evaluation of analytical methods and estimation of performance characteristics — Part 1: Statistical evaluation of the linear calibration function (www.iso.org)
  • ISO 8466-2:2001 Water quality – Calibration and evaluation of analytical methods and estimation of performance characteristics – Part 2: Calibration strategy for non-linear second-order calibration functions (iso.org)
  • ISO 15796:2005. Gas analysis – Investigation and treatment of analytical bias (www.iso.org)
  • ISO 16140-1:2016. Microbiology of the food chain – Method validation – Part 1: Vocabulary (www.iso.org)
  • ISO 16140-2:2016. Microbiology of the food chain – Method validation – Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method (www.iso.org)
  • ISO 16140-3:2021. Microbiology of the food chain – Method validation – Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (www.iso.org)
  • ISO 16140-4:2020. Microbiology of the food chain – Method validation – Part 4: Protocol for method validation in a single laboratory (www.iso.org)
  • ISO 16140-5:2020 Microbiology of the food chain – Method validation – Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods (www.iso.org)
  • ISO 16140-6:2019. Microbiology of the food chain – Method validation – Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures (www.iso.org)
  • ISO 20395:2019 Biotechnology - Requirements for evaluating the performance of quantification methods for nucleic acid target sequences - qPCR and dPCR (www.iso.org)

Guides

  • H. Cantwell (Ed.) Eurachem Guide: The Fitness for Purpose of Analytical Methods – A Laboratory Guide to Method Validation and Related Topics, (3rd ed. 2025) (www.eurachem.org)
  • M. H. Ramsey, P. D. Rostron, F. C. Raposo (Eds.) Eurachem/EUROLAB/CITAC/Nordtest/AMC Guide: Validation of Measurement Procedures that Include Sampling (2024) (www.eurachem.org)
  • V. Barwick (Ed.) Planning and Reporting Method Validation Studies – Supplement to Eurachem Guide on the Fitness for Purpose of Analytical Methods (2019) (www.eurachem.org)
  • H. Cantwell (Ed.) Blanks in Method Validation – Supplement to Eurachem Guide The Fitness for Purpose of Analytical Methods (2019) (www.eurachem.org)
  • ICH Bioanalytical method validation and study sample analysis M10 2022 (ich.org)
  • ICH Validation of Analytical Procedures: Text and Methodology Q2(R2) 2024 (ich.org)
  • ICH Analytical Procedure Development Q14 2024 (ich.org)
  • NordVal International Protocol for the validation of microbiological alternative (proprietary) methods against a reference method – Protocol No. 1 (January 2022) (nmkl.org)
  • Guidelines for validation of qualitative binary chemistry methods, Journal of AOAC INTERNATIONAL, Volume 97, Issue 5, September 2014, Pages 1492–1495, (aoac.org)
  • AOAC International Methods Committee Guidelines for Validation of Microbiological Methods for Food and Environmental Surfaces, 24 February 2012 (aoac.org)
  • Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline Second­ Edition (EP17-A2), CLSI, 2012 (clsi.org)
  • Guidance Document on the Estimation of LOQ for Measurements in the Field of Contaminants in Feed and Food, 2022, (https:\\eurl-pops.eu)
  • Guidance document on the estimation of LOD and LOQ for measurements in the field of contaminants in feed and food, P. Robouch, J. Stroka, J. Haedrich, et al., European Commission, Joint Research Centre , Publications Office, 2016 (https://data.europa.eu/doi/10.2787/8931)
  • EURL Guidance Document on Confirmation Method Validation, [Guidance included in Part III of the Guidance on validation in relation to residues of veterinary medicinal products] (https://food.ec.europa.eu/)
  • Analytical Quality Control and Method Validation Procedures for Pesticide Residue Analysis in Food and Feed SANTE 11312/2021
  • Procedure 4, Validation of chemical analytical methods, 3rd NMKL, 2009 (www.nmkl.org) 

Books

  • M. Feinberg and S. Rudaz, Quantification, validation and uncertainty in analytical sciences, Wiley – VCH, 2024, ISBN: 978-3-527-35332-3 
  • E. Voigtman, Limits of detection in chemical analysis, John Wiley & Sons, 2017, ISBN 978-1-119-18897-1
  • M. E. Swartz, I. S. Krull, Handbook of analytical validation, CRC Press, 2012, ISBN 978 0824706890
  • N. Majcen, P. Taylor, L. Benedik, Practical examples on traceability, measurement uncertainty and validation in chemistry Vol 1, 2010, European Commission, Joint Research Centre (https://bookshop.europa.eu/en/home/
  • N. Majcen, P. Taylor, T. Martišius, A. Menditto, M. Patriarca, Practical examples on traceability, measurement uncertainty and validation in chemistry Vol 2, 2011, European Commission, Joint Research Centre (https://bookshop.europa.eu/en/home/

Leaflets

Articles and reports

  • D. T. Burns, K. Danzer, A. Townshend. Use of the term "recovery" and "apparent recovery" in analytical procedures, IUPAC Recommendation 2002, Pure Appl. Chem., 2002, 74(11), 2201-2205, https://doi.org/10.1351/pac200274112201
  • M. Thompson, S. L. R. Ellison, R. Wood, Harmonised guidelines for single-laboratory validation of methods of analysis, IUPAC Technical report, Pure Appl. Chem., 2002, 74 (5), 835-855, https://doi.org/10.1351/pac200274050835
  • J. Vessman, R. I. Stefan, J. Van Staden, K. Anzer, W. Lindner, D. Thorburn Burns, A. Fajgelj, H. Müller. Selectivity in analytical chemistry, IUPAC Recommendation 2001, Pure Appl. Chem., 2001, 73(8), 1381-1386, http://dx.doi.org/10.1351/pac200173081381
  • M. Thompson, S. L. R. Ellison, A. Fajgelj, P. Willetts, R. Wood, Harmonized guidelines for the use of recovery information in analytical measurement, ISO, IUPAC and AOAC International Technical report, Pure Appl. Chem., 1999, 71 (2), 337-348, http://dx.doi.org/10.1351/pac199971020337
  • L. A. Currie, Nomenclature in evaluation of analytical methods including detection and quantification capabilities, IUPAC Recommendations 1995, Pure Appl. Chem., 1995, 67(10), 1699-1723, https://doi.org/10.1351/pac199567101699 (also available in Anal. Chim. Acta, 1999, 391,105-126, https://doi.org/10.1016/S0003-2670(99)00104-X)

Return to reading list >>

 

 

Details
Category: Reading list
Last Updated: Wednesday, 28 May 2025 06:54