The Fitness for Purpose of Analytical Methods (2014)
The Fitness for Purpose of Analytical Methods: A Laboratory Guide to Method Validation and Related Topics: Second edition (2014)
This guide was first issued in 1998, and has over the years been one of the most popular of the Eurachem guides. Since the release of the first edition, however, there have been many changes in terminology, working practices, reference documents and requirements. This second edition, produced by the Eurachem Method Validation Working Group, forms a thorough revision of the 1998 edition.
This second edition accommodates the main changes in international standards and practice. The new edition also includes notes on some aspects of validation that are specific to qualitative test methods.
This second edition includes guidance on:
- The concept of method validation;
- The background and rationale for method validation;
- How a method validation study should be performed and how much should be done (validation/verification);
- A thorough explanation of the various validation parameters (performance characteristics);
- Follow-up on the validation study (reporting, use of performance data in Internal Quality Control);
- Documentation of analytical methods.
Appendices also describe the statistical basis of detection limits and analysis of variance for precision studies, and add notes on qualitative analysis.
The Guide deals e.g. with the issues related to
"Instrument Working Range" vs. "Method Working Range"
In preparing this guidance, the Working Group has aimed at the right balance between giving a solid theoretical background for method validation studies and providing practical guidelines on how to plan, perform and evaluate such studies in the laboratories.
The approach is generic in the sense that the Guide does not focus on particular fields of application (food, environment, pharmaceuticals etc.). However, the guide includes references to a number of specific guides in fields where different practices have been developed and become common.
The guide also includes a full bibliography. Further literature references on method validation can be found in the section "Validation of analytical methods" in the Reading list on this website.
The Guide is available from this website in the following languages:
- Download the guide in English (Issued 2014) (pdf, 1.2 MB)
- Download the guide in Farsi (Issued April 2016) (pdf, 1.8 MB)
- Download the guide in Italian* (Issued February 2017) (pdf, 1.2 MB) NEW
- Download the guide in Spanish (Issued April 2016) (pdf, 1.0 MB)
- Download the guide in Ukrainian (Amended April 2016) (pdf, 1.1 MB)
In addition, a Russian translation is available on request from Dr. Mykhailo Rozhnov, Ukrainian Centre for Standardisation, Metrology and Certification (Ukrmetrteststandart), who can be contacted using the relevant contact form on this website.
*Italian version also available at http://www.iss.it/binary/publ/cont/16_39_web.pdf
This publication should be cited* as:
"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. Available from http://www.eurachem.org"
*Subject to journal requirements
Translation into other languages is permitted for members of Eurachem. Please contact the Eurachem Secretariat for details.
The 1998 edition of this guide can be found here for reference.
- Last Updated: Wednesday, 15 February 2017 23:54