The Fitness for Purpose of Analytical Methods

The Fitness for Purpose of Analytical Methods

A Laboratory Guide to Method Validation and Related Topics

Second Edition 2014

Eurachem Guide

The Fitness for Purpose of Analytical Methods

A Laboratory Guide to Method Validation and Related Topics

Second edition

Acknowledgements

This document has been produced by members of the Eurachem Method Validation Working Group and others co-opted for this task. Those who have contributed to this edition are listed below.

Project group

Vicki Barwick Pedro P. Morillas Bravo Stephen L. R. Ellison Joakim Engman Elin L. F. Gjengedal Ulla Oxenb?ll Lund Bertil Magnusson (editor) Hans-Thomas M?ller Marina Patriarca Barbara Pohl Piotr Robouch Lorens P. Sibbesen (chairman) Elvar Theodorsson Florent Vanstapel Isabelle Vercruysse Aysun Yilmaz Perihan Yolci ?meroglu Ulf ?rnemark (editor)

LGC (UK) Canal de Isabel II Gesti?n (ES) LGC (UK) National Food Agency (SE) Norwegian University of Life Sciences (NO) Eurofins Milj? A/S (DK) SP Technical Research Institute of Sweden (SE) Mersin (TR) Istituto Superiore di Sanit? (IT) Merck KGaA (DE) European Commission (EU) Labquality International (DK) University Hospital in Link?ping (SE) University Hospital Leuven, Leuven (BE) BELAB (BE) Cevre Food and Industrial Analysis Laboratory (TR) Okan University (TR) Emendo Dokumentgranskning (SE)

Copyright ?

Copyright of this document is held by the contributing authors. All enquiries regarding reproduction in any medium, including translation, should be directed to the Eurachem secretariat. The text may not be copied for resale.

Recommended citation

This publication should be cited* as: "B. Magnusson and U. ?rnemark (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 ."

*Subject to journal requirements

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The Fitness for Purpose of Analytical Methods

Eurachem Guide

Contents

Foreword to the second edition................................................................................................. 1

Foreword to the first edition ..................................................................................................... 2

Abbreviations and symbols........................................................................................................ 3

1 Introduction........................................................................................................................ 5

1.1 Rationale and scope for this Guide ...................................................................................... 5

1.2 Notes on the use of this Guide .............................................................................................. 5

1.2.1 Terminology ...................................................................................................................................... 5 1.2.2 Quick References .............................................................................................................................. 6

2 What is method validation? ............................................................................................... 7

2.1 Definitions .............................................................................................................................. 7

2.2 What is the difference between validation and verification? ............................................ 7

3 Why is method validation necessary?................................................................................ 9

3.1 Importance of analytical measurement ............................................................................... 9

3.2 The professional duty of the analytical chemist.................................................................. 9

3.3 Method development ............................................................................................................. 9

4 When should methods be validated or verified? ............................................................. 11

4.1 Method validation................................................................................................................ 11

4.2 Method verification ............................................................................................................. 11

5 How should methods be validated? ................................................................................. 13

5.1 Who carries out method validation?.................................................................................. 13

5.1.1 Approaches to method validation.....................................................................................................13 5.1.2 Interlaboratory approach ..................................................................................................................13 5.1.3 Single-laboratory approach ..............................................................................................................13

5.2 Extent of validation studies ................................................................................................ 13

5.3 Validation plan and report ................................................................................................. 14

5.4 Validation tools .................................................................................................................... 15

5.4.1 Blanks...............................................................................................................................................15 5.4.2 Routine test samples.........................................................................................................................15 5.4.3 Spiked materials/solutions................................................................................................................15 5.4.4 Incurred materials.............................................................................................................................15 5.4.5 Measurement standards ....................................................................................................................15 5.4.6 Statistics ...........................................................................................................................................16

5.5 Validation requirements ..................................................................................................... 16

5.6 Method validation process .................................................................................................. 16

6 Method performance characteristics............................................................................... 19

6.1 Selectivity ............................................................................................................................. 19

6.1.1 Terms and definitions.......................................................................................................................19 6.1.2 Effects of interferences.....................................................................................................................19 6.1.3 Assessment of selectivity .................................................................................................................19

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