The Fitness for Purpose of Analytical Methods (2014)
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- Last Updated: Tuesday, 24 May 2022 00:45
Full title
The Fitness for Purpose of Analytical Methods: A Laboratory Guide to Method Validation and Related Topics: Second edition (2014)
Quick links:
- Overview of the guide
- Downloads
- Citing the guide
- Supplementary guidance on method validation topics
- Providing comments and feedback
- Previous versions
Introduction
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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. |
Contents
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.
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.
Availability
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 German (Issued May 2017) (pdf, 860 kB)
- Download the guide in Italian* (Issued February 2017) (pdf, 1.2 MB)
- Download the guide in Spanish (Issued April 2016) (pdf, 1.0 MB)
- Download the guide in Turkish (Issued July 2018) (pdf, 890 kB)
- Download the guide in Ukrainian (Amended April 2016) (pdf, 1.1 MB)
In addition:
- The Czech translation by Eurachem-CZ can be ordered from http://www.eurachem.cz/publikace-detail.php?clanek=14
- 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
Citation
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
Supplementary guidance
The supplementary guidance below gives additional guidance on method validation topics:
- Planning and reporting method validation studies. This supplement is in the form of a template which can be used to assist with planning the evaluation of the chosen performance characteristics
- Blanks in method validation. This short supplement describes the different types of blanks which may be used during method validation and provides guidance for situations where it may be difficult to obtain a suitable blank matrix.
Translations
Translation into other languages is permitted for members of Eurachem. Other offers of translation should be directed to the Eurachem Secretariat for permission. The Eurachem policy on maintenance and development of Eurachem guidance, available on the Policies page, gives further information on translation.
Review/revision of the guide
The MVWG has started the process of reviewing the 2nd version (2014) of the guide with regard to a revision into a 3rd version.
The MVWG is always interested in feed-back from users of the guide, who are welcome to make their comments by use of the Feedback form on the Eurachem Fitness for Purpose guide (opens on another site)
Previous version
The 1998 edition of this guide can be found here for reference.
Planning is an essential stage in the validation process. Before starting any experimental work, the aim should be to have a clear plan for the entire validation study. This should cover the performance characteristics that will be studied, the target value for each performance characteristic, the materials that will be analysed, the level of replication and order of the experiments, any statistical analysis that will be used, and how the method will be judged as being fit for purpose.
Many decisions with socio-economic or individual impact depend on qualitative analysis, including decisions related to food safety, clinical diagnosis, and forensic evidence, are based primarily on qualitative, rather than quantitative, chemical analysis. Qualitative analysis is analysis that returns a classification rather than a numerical value, such as the identity of a chemical substance, the type of plastic of a microparticle, the potential source of an oil spill, the presence of a banned sports doping substance, or the presence of accelerant in fire debris. Sometimes, such classifications rely solely on qualitative tests; others may use measurement results (such as line frequencies in a spectrum) to reach a conclusion.
Blanks are an important tool and are used in the determination of most performance characteristics during a validation process. They are also often included in each analytical run during routine use of the measurement procedure. There are many different types of blanks and the analyst must consider which blanks to include during preparation of the validation plan.
This Guide gives detailed guidance for the establishment of metrological traceability in quantitative chemical analysis, based on the definition in the international vocabulary of basic and general terms in metrology (VIM). Though it is aimed principally at testing and measurement laboratories carrying out chemical measurement, the principles are expected to apply from routine analysis to basic research. The document is intended to assist laboratories in meeting the requirements on traceability of results given in ISO/IEC 17025.