Guides

Guides

Current Eurachem Guides

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)

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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:

*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. 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 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.

 

Quality Assurance for Research and Development and Non-routine Analysis (1998)

Contents

This guide, produced by a joint Eurachem/CITAC working party representing industrial, academic, and governmental interests, promotes and describes the concepts of quality assurance in the non-routine environment. The guide promotes a nested approach to quality assurance, dealing with it at a general organisational level, a technical level and a project specific level. It is intended to promote the use of QA as an effective tool for establishing and maintaining quality in R&D and non-routine operations. It does not seek to set criteria for accreditation of R&D although there is a section describing various methods for third party assessment of quality systems. The guidance may form the basis on which accreditation criteria can be set in the future. The guidance is intended to complement the existing CITAC guide (CG1) which describes QA in the routine environment. It is primarily directed towards analytical chemistry establishments but is, in principle, applicable to other sectors. An extensive bibliography is included.

Availability

The English language version (edition 1.0 1998) is available from the UK National Measurement System Chemical and Biological Metrology programme.

Download the guide from this website (new window) (pdf, 203 kB).

Translations

A German language version can be downloaded from the Eurachem/DE website documents page. (Opens new Browser window).

Harmonised Guidelines for the Use of Recovery Information in Analytical Measurements (1998)

This guide was produced by IUPAC with contributions from Eurachem.

Contents

It is recognised that the use of recovery information to correct/adjust analytical results is a contentious one for analytical chemists. Different sectors of analytical chemistry have different practices. Formal legislative requirements with regard to the use of recovery factors also vary sector-to-sector. It is the aim of IUPAC, however, to prepare general Guidelines which may be seen to aid the preparation of the “best estimate of the true result” and to contribute to the comparability of the analytical results reported. IUPAC Interdivisional Working Party on Harmonisation of Quality Assurance Schemes for Analytical Laboratories has co-operated with the International Organisation for Standardisation (ISO), the International Association of Official Analytical Chemists (AOAC Int.) and Eurachem to produce this guide. On the basis of contributions presented at the Symposium on Harmonisation of Quality Assurance Systems for Analytical Laboratories dedicated to the “Use of Recovery Factors in Analytical Chemistry” (September 1996, Orlando, USA; sponsored by IUPAC, ISO and AOAC Int.) a final document was prepared for publication by M. Thompson, S. L. R. Ellison, A. Fajgelj, P. Willetts and R. Wood. The document was submitted for publication in Pure and Applied Chemistry.
This document attempts to give Guidelines that are intended to be general in their scope and give recommendations that reflect common practice best able to achieve the comparability of analytical results. However, specific sectors of analytical chemistry will need to develop these Guidelines for their own requirements and the recommendations are not, therefore, to be seen as binding for all areas of analytical chemistry.

Availability

An English language version is available from A. Fajgelj, Quality Assurance Supervisor, International Atomic Energy Agency, Agency's Laboratories Seibersdorf, 2444 Seibersdorf, Austria. Tel.: +43 1 2600 28233, Fax: + 43 1 2600 28222, E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.. Alternatively, you may download the guide from this website (pdf, 73 kB).

Translations

No other translations are currently available.

Use of uncertainty information in compliance assessment. (2007)

Content

Stringent and relaxed acceptance 230x200In order to decide whether a result indicates compliance or non-compliance with a specification, it is necessary to take into account the measurement uncertainty associated with the result. This guide provides guidance on how uncertainty may be taken into account in deciding compliance with a limit.

The guide is applicable to decisions on compliance with regulatory or manufacturing limits where a decision is made on the basis of a measurement result accompanied by information on the uncertainty associated with the result. It covers cases where the uncertainty does not depend on the value of the measurand, and cases where the uncertainty is proportional to the value of the measurand.

The guide includes a discussion and general recommendations, followed by more detailed instructions on establishing rules for interpretation and by several examples.

Availability

Downloads are available in two formats:

Hard copy is available via print-on-demand.
Note: This service is provided through a commercial company, Lulu.com. Proceeds support the Eurachem Secretariat

Translations

This guide is additionally available in Farsi and Portuguese.

Translation into other languages is permitted for members of Eurachem.

Citation

This guidance should be cited* as
"S L R Ellison and A Williams (Eds). Eurachem/CITAC guide: Use of uncertainty information in compliance assessment. (First Edition (2007).  Available from www.eurachem.org."

*Subject to journal requirements.