Guides

Guides

Current Eurachem Guides

Blanks in method validation

A Supplement to the Eurachem Guide "The Fitness for Purpose of
Analytical Methods"

Contents

Cover of 'blanks' supplementBlanks 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 supplementary guidance 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. It is intended to be used in conjunction with "The Fitness for Purpose of Analytical Methods - A Laboratory Guide to Method Validation and Related Topics (2nd ed.)"

Availability

This supplementary guidance is available in the following languages:

Citation

This publication should be cited* as:
"H. Cantwell (ed.) Blanks in Method Validation - Supplement to Eurachem Guide The Fitness for Purpose of Analytical Methods, (1st ed. 2019). Available from http://www.eurachem.org"

*Subject to journal requirements

Translations

Translation into other languages is permitted for members of Eurachem.

Guide to Quality in Analytical Chemistry - 3rd edition (2016)

Content

QAC 2016 cover 180hThe aim of this guide is to provide laboratories with guidance on best practice for the analytical operations they carry out. The guidance covers both qualitative and quantitative analysis carried out on a routine or non-routine basis. A separate guide covers research and development work (Quality Assurance for Research and Development and Non-routine Analysis,1998 ).

This third edition is a revision of the CITAC/Eurachem Guide published in 2002. The 2002 edition was developed from CITAC Guide 1 (which in turn was based on the Eurachem/WELAC Guide). The third edition reflects changes that were introduced with the publication of the 2005 version of ISO/IEC 17025. The terminology has also been updated to take account of ISO/IEC 17000:2004, ISO 9000:2015 and the 3rd edition of the International Vocabulary of Metrology – Basic and general concepts and associated terms (JCGM 200:2012 – VIM).

The Guide focuses on the requirements of ISO/IEC 17025, however the content should also be of use to organisations seeking accreditation or certification against the requirements of standards such as ISO 15189 or ISO 9001, or compliance with the Principles of Good Laboratory Practice

Availability

You may download the guide from this website at no cost (pdf, 960 kB).

Translations

Versions are currently available in

Translation into other languages is permitted for members of Eurachem.

Publication date

This third edition was approved for publication in December 2016 and first published on this website on 25 January 2017.

Setting and Using Target Uncertainty in Chemical Measurement

Contents

The Eurachem/CITAC Measurement uncertainty and traceability working group has prepared this Guide to as part of a sequence of guidelines that aims at promoting the production of measurement results that are traceable to an adequate reference and are reported with reliable and sufficiently low uncertainty for the intended use of the measurement. These features are essential for the adequate interpretation of the measurement result which is discussed in the Eurachem/CITAC guide, ‘Use of uncertainty information in compliance assessment’.

This document discusses how to set a maximum admissible uncertainty, defined in the third edition of the International Vocabulary of Metrology as the “target uncertainty”, to check whether measurement quality quantified by the measurement uncertainty is fit for the intended purpose.

Target MU 178pxThis guideline is applicable to analytical fields where the target uncertainty is not set by the regulator or the client, or where a minimum difference of the studied parameter in the same or different items must be detected in R&D work. This guide discusses how to set the target uncertainty for process development and for applied or fundamental research using information about the smallest difference or system trend that must be distinguished in a reliable way.

This guideline can also be useful for authorities and stakeholders that feel the need to define or upgrade criteria for measurements quality. The setting of target values for the so called conventional performance characteristics (precision, trueness, etc.) can miss the control of important uncertainty components included in sound uncertainty evaluations.

The document fills a gap in the current list of guidance for measurements in chemistry and can contribute to ensuring measurements play their role in the management of socio-economic interests and in the technological and scientific developments of society.

Availability

You may download the Guide from this website at no cost. 

Translations

Translation into other languages is permitted for members of Eurachem. Other offers of translation are subject to approval by the Eurachem Executive and should be directed to the Eurachem Secretary.

Recommended citation

This publication should be cited* as: “R. Bettencourt da Silva, A. Williams (Eds), Eurachem/CITAC Guide: Setting and Using Target Uncertainty in Chemical Measurement, (1st ed. 2015). Available from www.eurachem.org.”
*Subject to journal requirements

Approval and publication

This guide was approved for publication** by the Eurachem GA in May 2015 and first published on this website on 2015-09-28.
**Subject to minor comments

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.