The Eurachem reading list

5. Validation of analytical methods

Standards

  • ASTM E1169–18. 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 5725-2:1994. 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 (and Technical Corrigendum 1:2002). (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 5725-4:1994. 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 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/TR 13843:2017. Water quality — Guidance on validation of microbiological methods (www.iso.org)
  • ISO/TR 22971:2017. Accuracy (trueness and precision) of measurement methods and results -- Practical guidance for the use of ISO 5725-2:1994 in designing, implementing and statistically analysing interlaboratory repeatability and reproducibility results. (www.iso.org)

Guides

  • B. Magnusson, U. Örnemark (Eds), The fitness for purpose of analytical methods. A laboratory guide to method validation and related topics, 2nd Edition, Eurachem, 2014, ISBN 978-91-87461-59-0 (www.eurachem.org)
  • Guidelines for validation of qualitative binary chemistry methods, AOAC International Stakeholder Panel on Alternative Methods, Approved March 14, 2013 (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/)
  • AOAC International. How to Meet ISO 17025 Requirements for Method Verification. AOAC/ ALACC, 2007 (www.aoac.org)
  • ICH Validation of Analytical Procedures :Text and Methodology Q2(R1) 2005 (www.ich.org)

Books

  • 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
  • In-house method validation: A guide for chemical laboratories, LGC, 2003, ISBN 0 948926 18 X (www.lgcgroup.com/nml)
  • C. Burgess, Valid analytical methods and procedures, RSC, 2000, ISBN 978 0 85404 482 5

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 (www.degruyter.com/pac)
  • 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 (www.degruyter.com/pac)
  • 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 (www.degruyter.com/pac)
  • 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 (www.degruyter.com/pac)
  • 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 (www.degruyter.com/pac) (also available in Analytica Chimica Acta, 1999, 391,105-126)
  • W. Horwitz, Protocol for the design, conduct and interpretation of method performance studies, Pure Appl. Chem., 1995, 67, 331-343 (www.degruyter.com/pac)
  • Eurolab cookbooks (www.eurolab.org/cookbooks.aspx)
    • Doc No. 1.0, Validation of test and calibration methods, 2017
    • Doc No. 15, The assessment of trueness of a measurement procedure by use of a reference material (RM), 2012
  • AMC Technical Briefs, RSC, (www.rsc.org/Membership/Networking/InterestGroups/Analytical/AMC/TechnicalBriefs.asp):
    • 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?

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