The Eurachem reading list

7. Validation of analytical methods

Standards

  • ASTM E1169 – 21. Standard practice for conducting ruggedness tests. ASTM International (www.astm.org)
  • ISO 5725-1:1994. Accuracy (trueness and precision) of measurement methods and results – Part 1: General principles and definitions (and Corrigendum 1:1998) (www.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 5725-3:1994. 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 11843-1:1997. Capability of detection – Part 1: Terms and definitions (and Technical Corrigendum 1: 2003) (www.iso.org)
  • ISO 11843-2: 2000. Capability of detection – Part 2: Methodology in the linear calibration case (and Technical Corrigendum 1:2007) (www.iso.org)
  • ISO 11843-5:2008. Capability of detection – Part 5: Methodology in the linear and non-linear calibration cases (and Amendment 1:2017) (www.iso.org)
  • ISO 13843:2017. Water quality – Requirements for establishing performance characteristics of quantitative microbiological methods (www.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

  • ICH Bioanalytical method validation and study sample analysis M10 2022 (www.ich.org)
  • B. Magnusson and U. Örnemark (Eds) Eurachem Guide: The fitness for purpose of analytical methods. A laboratory guide to method validation and related topics, (2nd ed 2014) ISBN 978-91-87461-59-0 (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)
  • NordVal International Protocol for the validation of microbiological alternative (proprietary) methods against a reference method – Protocol No. 1 (January 2022) (www.nmkl.org)
  • Guidelines for validation of qualitative binary chemistry methods, AOAC International Stakeholder Panel on Alternative Methods, Approved 2014 (www.aoac.org)
  • AOAC International Methods Committee Guidelines for Validation of Microbiological Methods for Food and Environmental Surfaces, 24 February 2012 (www.aoac.org)
  • Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline Second Edition (EP17-A2), CLSI, 2012 (www.clsi.org)
  • 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/)
  • 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/)
  • ICH Validation of Analytical Procedures :Text and Methodology Q2(R1) 2005 (www.ich.org)

Books

  • E. Voigtman, Limits of detection in chemical analysis, John Wiley & Sons, 2017, ISBN 978-1-119-18897-1
  • M. L. J. Weitzel, W. M. Johnson, Application of ISO/IEC 17025 technical requirements in industrial laboratories: Method validation, FriesenPress, 2013, ISBN 978 1460210277
  • M. E. Swartz, I. S. Krull, Handbook of analytical validation, CRC Press, 2012, ISBN 978 0824706890
  • L. Huber, Validation and qualification in analytical laboratories, 2nd Edition, Informa Healthcare, 2007, ISBN 978 0849382673
  • C. Burgess, Valid analytical methods and procedures, RSC, 2000, ISBN 978 0 85404 482 5

Leaflets

  • Eurachem information leaflets (www.eurachem.org)
    • The importance of method validation (2021)
    • Treatment of an observed bias (2017)
  • Eurolab cookbooks (https://www.eurolab.org/pubs-cookbooks)
    • Doc No. 1, Selection, verification and validation of methods, revision no. 4, 07/2020
    • Doc No. 15, The assessment of the trueness of a measurement procedure by use of a reference material (RM), revision no. 3, 10/2018
  • AMC Technical Briefs, RSC, (https://www.rsc.org/membership-and-community/connect-with-others/join-scientific-networks/subject-communities/analytical-science-community/amc/technical-briefs/):
    • AMC TB 110-2022 Summarising the precision statistics from collaborative trials
    • AMC TB 92-2020, The edge of reason: reporting and inference near the detection limit
    • AMC TB 70-2015, An analyst's guide to precision
    • AMC TB 17-2004, The amazing Horwitz function
    • AMC TB 13-2003, Terminology - the key to understanding analytical science. Part 1: Accuracy, precision and uncertainty
    • AMC TB 05-2001, What should be done with results below the detection limit? Mentioning the unmentionable
    • AMC TB 03-2005 (revised December 2005), Is my calibration linear?

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)

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Last Updated: Friday, 16 June 2023 12:01