Standards

• ASTM E1169 – 21. Standard practice for conducting ruggedness tests. ASTM International (www.astm.org)
• 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 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

• Magnusson and U. Örnemark (Eds) Eurachem Guide: The fitness for purpose of analytical methods. A laboratory guide to method validation and related topics (2^nd ed. 2014) ISBN 978-91-87461-59-0 (www.eurachem.org)
• Barwick (Ed.) Planning and Reporting Method Validation Studies – Supplement to Eurachem Guide on the Fitness for Purpose of Analytical Methods (2019) (www.eurachem.org)
• 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) (nmkl.org)
• Guidelines for validation of qualitative binary chemistry methods, AOAC International Stakeholder Panel on Alternative Methods, Approved 2014 (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)
• 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) 
• 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, (https://food.ec.europa.eu/)
• Analytical Quality Control and Method Validation Procedures for Pesticide Residue Analysis in Food and Feed  SANTE 11312/2021
• Guidance on validation in relation to residues of veterinary medicinal products. (https://food.ec.europa.eu/)
• Procedure 4, Validation of chemical analytical methods, 3^rd NMKL, 2009 (www.nmkl.org) 

Books

• Voigtman, Limits of detection in chemical analysis, John Wiley & Sons, 2017, ISBN 978-1-119-18897-1
• E. Swartz, I. S. Krull, Handbook of analytical validation, CRC Press, 2012, ISBN 978 0824706890
• 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/
• 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/
• Huber, Validation and qualification in analytical laboratories, 2^nd Edition, Informa Healthcare, 2007, ISBN 978 0849382673

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, https://doi.org/10.1039/D2AY90010F
  • AMC TB 92-2020, The edge of reason: reporting and inference near the detection limit, https://doi.org/10.1039/C9AY90188D
  • AMC TB 70-2015, An analyst's guide to precision, https://doi.org/10.1039/C5AY90071A
• Under Statistical Analysis tab:
  • AMC TB 17-2004, The amazing Horwitz function
  • 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?

• Under Metrology tab:

  • AMC TB 13-2003, Terminology – the key to understanding analytical science. Part 1: Accuracy, precision and uncertainty

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: Tuesday, 14 May 2024 21:15

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