Eure Chem
Eure Chem
Eure Chem
Validation of analytical methods
Search Search ...
Member login
Username
Password
Remember Me
Log in
Forgot your password?
Forgot your username?
The Eurachem reading list
5. Validation of analytical methods
Standards
ASTM E691–16. Standard practice for conducting an interlaboratory study to determine the precision of a test
method. ASTM International (www.astm.org)
ASTM E1169–14. Standard practice for conducting ruggedness tests. ASTM International (www.astm.org)
ISO 57251:1994. Accuracy (trueness and precision) of measurement methods and results Part 1: General
principles and definitions (and Corrigendum 1:1998). (www.iso.org)
ISO 57252:1994. 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 57253:1994. 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 57254:1994. 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 57255:1998. 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 57256:1994. Accuracy (trueness and precision) of measurement methods and results Part 6: Use in
practice of accuracy values (and Corrigendum 1: 2001). (www.iso.org)
https://www.eurachem.org/index.php/publications/mnurdlst/130rdlvalidation 1/5
1/8/2018 5. Validation of analytical methods
ISO 118431:1997. Capability of detection Part 1: Terms and definitions (and Technical Corrigendum 1: 2003).
(www.iso.org)
ISO 118432 2000. Capability of detection Part 2: Methodology in the linear calibration case (and Technical
Corrigendum 1:2007) (www.iso.org)
ISO 118435:2008. Capability of detection Part 5: Methodology in the linear and nonlinear calibration cases.
(www.iso.org)
ISO/TR 13843:2000. Water quality — Guidance on validation of microbiological methods (www.iso.org)
ISO/TR 22971:2005. Accuracy (trueness and precision) of measurement methods and results Practical
guidance for the use of ISO 57252:1994 in designing, implementing and statistically analysing interlaboratory
repeatability and reproducibility results. (www.iso.org)
Guides
Guide to Method Validation for Quantitative Analysis in Chemical Laboratories, PS15, issue 4 February 2016, Irish
National Accreditation Board (www.inab.ie)
Guidance document on analytical quality control and method validation procedures for pesticides residues
analysis in food and feed, SANTE/11945/2015
(http://ec.europa.eu/food/plant/docs/plant_pesticides_mrl_guidelines_wrkdoc_11945_en.pdf)
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 9789187461590 (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)
Guidelines for the validation and verification of quantitative and qualitative test methods, Technical Note 17,
NATA, 2013 (www.nata.com.au)
Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline Second Edition
(EP17A2), 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/)
Guidelines for the implementation of decision 2002/657/EC, SANCO/2004/2726rev 4December 2008
(http//ec.europa.eu/food/safety/docs/cs_vetmedresidues_cons_20042726rev4_en.pdf)
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)
Validation of test methods. General principles and concepts, 4/96 (In cooperation with EAL, European cooperation
for Accreditation of Laboratories), 1996 (www.eurolab.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
https://www.eurachem.org/index.php/publications/mnurdlst/130rdlvalidation 2/5
1/8/2018 5. Validation of analytical methods
L. Huber, Validation and qualification in analytical laboratories, 2nd Edition, Informa Healthcare, 2007, ISBN 978
0849382673
J. Ermer, J. H. McB. Miller (Eds), Method validation in pharmaceutical analysis: A guide to best practice, Wiley
VCH, 2005, ISBN 978 3 527 31255 9
C. C. Chan, Y. C. Lee, H. Lam, X.M. Zhang, Analytical method validation and instrument performance
verification, John Wiley & Sons Inc., 2004, ISBN 978 0 471 25953 4
Inhouse method validation: A guide for chemical laboratories, LGC, 2003, ISBN 0 948926 18 X
(www.lgcgroup.com/nmi)
C. Burgess, Valid analytical methods and procedures, RSC, 2000, ISBN 978 0 85404 482 5
A. Fajgelj, A. Ambrus, Principles and Practices of Method Validation Proceedings (Special Publication), RSC,
2000, ISBN 9780854047833
W. Hardcastle, Qualitative analysis A guide to best practice, RSC, 1998, ISBN 0 85404 462 0
Articles and reports
J. Van Loco, A. J'anosi, S. Impens, S. Fraselle, V. Cornet, J.M. Degroodt. Calculation of the decision limit (CCα)
and the detection capability (CCβ) for banned substances: The imperfect marriage between the quantitative and
the qualitative criteria, Anal. Chim. Acta, 2007, 586, 8–12 (www.sciencedirect.com)
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), 22012205 (www.iupac.org)
Guidelines for collaborative study procedures to validate characteristics of a method of analysis (Appendix D),
AOAC Official methods of Analysis, 2002, AOAC International (www.aoac.org)
M. Thompson, S. L. R. Ellison, R. Wood, Harmonised guidelines for singlelaboratory validation of methods of
analysis, IUPAC Technical report, Pure Appl. Chem., 2002, 74 (5), 835855 (www.iupac.org)
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), 13811386
(www.iupac.org)
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), 337348 (www.iupac.org)
L. A. Currie, Nomenclature in evaluation of analytical methods including detection and quantification capabilities,
IUPAC Recommendations 1995, Pure Appl. Chem., 1995, 67(10), 16991723 (www.iupac.org) (also available in
Analytica Chimica Acta, 1999, 391,105126)
W. Horwitz, Protocol for the design, conduct and interpretation of method performance studies, Pure Appl.
Chem., 1995, 67, 331343 (www.iupac.org)
Eurolab cookbooks (www.eurolab.org/cookbooks.aspx)
Doc No. 15, The assessment of trueness of a measurement procedure by use of a reference material
(RM), 2012
Doc No. 1.0, Validation of test and calibration methods, 2008
AMC Technical Briefs, RSC,
(www.rsc.org/Membership/Networking/InterestGroups/Analytical/AMC/TechnicalBriefs.asp):
AMC TB 702015, An analyst's guide to precision
AMC TB 172004, The amazing Horwitz function
https://www.eurachem.org/index.php/publications/mnurdlst/130rdlvalidation 3/5
1/8/2018 5. Validation of analytical methods
AMC TB 132003, Terminology the key to understanding analytical science. Part 1: Accuracy, precision
and uncertainty
AMC TB 052001, What should be done with results below the detection limit? Mentioning the
unmentionable
AMC TB 032005 (revised December 2005), Is my calibration linear?
Return to reading list >>
Category: Reading list
Last Updated: Monday, 24 April 2017 13:13
Statistics
Validation
Prev
Next
Frequently requested
Measurement Uncertainty
Eurachem working groups
Eurachem a quick reference
Eurachem Newsletter
Eurachem History and Impact
Proficiency Testing
Recent updates
Quantifying Uncertainty in Analytical Measurement, 2nd Edition (2000)
ISO/IEC 17025:2017 – First impressions
Eurachem Guide to Quality in Analytical Chemistry available in Czech
Guide to Quality in Analytical Chemistry 3rd edition (2016)
9th International Workshop on Proficiency Testing (2017)
New PT leaflet translations available
Eurachem on Twitter
https://www.eurachem.org/index.php/publications/mnurdlst/130rdlvalidation 4/5
1/8/2018 5. Validation of analytical methods
Tweets by @EurachemEurope
Eurachem Retweeted
EA Accreditation
@EAaccreditation
Get all the news of #EA in @IAF_Global newsletter: #GeneralAssembly #CETAProtocol
#EuropeanUnionAgencyforRailways
2 Jan 2018
Eurachem Retweeted
Labquality Days
@LabqualityDays
Download the congress flyer here labqualitydays.fi/wpcontent/upl… #LQD2018
29 Dec 2017
Eurachem Retweeted
Follow @EurachemEurope
https://www.eurachem.org/index.php/publications/mnurdlst/130rdlvalidation 5/5