The Fitness for Purpose of Analytical Methods (2014)

Full title

The Fitness for Purpose of Analytical Methods: A Laboratory Guide to Method Validation and Related Topics: Second edition (2014)

Quick links:

Introduction

Frontcover Validation Guide 90

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:

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

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:

  • 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. Please contact the  Eurachem Secretariat for details.

Review/revision of the guide

The MVWG has started the process of reviewing the 2nd version (2014) of the guide for possible revision into a 3rd version.
For that purpose a survey has been established for all users of the guide to give their opinion on the present version and suggestions for possible revisions of the various parts of the guide.
Please take a little time for completing the questionnaire under the link below. The MVWG appreciate any comments and will take them into consideration in their further work with the guide.
Inputs to the survey should be given at September 20 2019 at the latest. Thank you.

Survey on need for revision of the "Fitness for Purpose Guide"

Previous version

The 1998 edition of this guide can be found here for reference.