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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.

The aim of this supplement is to describe the different types of blanks which may be used during method validation and to provide 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 (3rd 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, (2nd ed. 2025). Available from http://www.eurachem.org"

*Subject to journal requirements

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.

The previous edition of this supplement is available in a number of translations. Please see previous editions here.

 

Previous Editions

The first edition of this supplement, and its translations, is available here.

Planning and Reporting Method Validation Studies

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

Contents

Cover of method validation 'Planning' supplementPlanning 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.

This supplement provides guidance on the planning and reporting of validation studies. The document is structured in the form of a template which can be used to assist with planning the evaluation of the chosen performance characteristics. The template is structured such that once the experimental work has been completed, the document can be easily converted into a validation report. The supplement also contains a checklist to assist with validation planning.

This supplement is intended to be used in conjunction with "The Fitness for Purpose of Analytical Methods - A Laboratory Guide to Method Validation and Related Topics (3rd ed.)

Availability

This supplementary guidance is available in the following languages:

 

Citation

This publication should be cited* as:
“V. Barwick (ed.), Planning and Reporting Method Validation Studies – Supplement to Eurachem Guide on the Fitness for Purpose of Analytical Methods (2nd ed. 2025). Available from http://www.eurachem.org"

*Subject to journal requirements

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.

The previous edition of this supplement is available in a number of translations, see previous editions below.

 

Previous Editions

The first edition of this supplement, and its translations, is available here.

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. 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.

Publication date

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

Citation

This publication should be cited* as:

“V. Barwick (Ed), Eurachem/CITAC Guide: Guide to Quality in Analytical Chemistry: An Aid to Accreditation (3rd ed. 2016). ISBN 978-0-948926-32-7. Available from www.eurachem.org.”

*Subject to journal requirements

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. 

NB: See also "Comments and errata" below.

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.

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). ISBN: 978-989-98723-7-0. 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

Comments and errata

Since publication of the Guide in 2015, a number of minor typographical issues have been identified. Although not sufficient to justify revision and re-issue of the complete Guide and translations, the Measurement Uncertainty and Traceability WG have prepared a list of comments and corrections for reader information. These are likely to be implemented in future editions.