Harmonized guidelines for singlelaboratory validation of methods of analysis

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Pure Appl. Chem., Vol. 74, No. 5, pp. 835–855, 2002.
© 2002 IUPAC
INTERNATIONAL UNION OF PURE AND APPLIED CHEMISTRY
ANALYTICAL, APPLIED, CLINICAL, INORGANIC, AND
PHYSICAL CHEMISTRY DIVISIONS
INTERDIVISIONAL WORKING PARTY FOR HARMONIZATION OF
QUALITY ASSURANCE SCHEMES FOR ANALYTICAL LABORATORIES*

HARMONIZED GUIDELINES FOR SINGLELABORATORY VALIDATION OF METHODS OF
ANALYSIS
(IUPACTechnical Report)
Resulting from the Symposium on Harmonization of Quality Assurance Systems for Analytical
Laboratories, Budapest, Hungary, 4–5 November 1999, held under the sponsorship of IUPAC, ISO,
and AOAC International
Prepared for publication by
MICHAEL THOMPSON1, STEPHEN L. R. ELLISON2, AND ROGER WOOD3,‡
1Department of Chemistry, Birkbeck College (University of London), London WC1H 0PP,UK;
2Laboratory of the Government Chemist, Queens Road, Teddington, Middlesex TW11 0LY, UK;
3Food

Standards Agency, c/o Institute of Food Research, Norwich Research Park, Colney, Norwich,
NR4 7UA, UK

*Membership of the Working Party during 1997–2000 was as follows:
Chairman: A. Fajgelj, 1997– , (IAEA, Austria); Members: K. Bergknut (Norway); Carmen Camara (Spain);
K. Camman (Germany);Jyette Molin Christensen (Denmark); S. Coates (AOAC Int., USA); P. De Bièvre
(Belgium); S. L. R. Ellison (UK); T. Gills (USA); J. Hlavay (Hungary); D. G. Holcombe (UK); P. T. Holland (New
Zealand); W. Horwitz (USA); A. Kallner (Sweden); H. Klich (Germany); E. A. Maier (Belgium); C. Nieto De
Castro (Portugal); M. Parkany (Switzerland); J. Pauwels (Belgium); M. Thompson (UK); M. J. Vernengo(Argentina); R. Wood (UK).
‡Corresponding

author

Republication or reproduction of this report or its storage and/or dissemination by electronic means is permitted without the
need for formal IUPAC permission on condition that an acknowledgment, with full reference to the source, along with use of the
copyright symbol ©, the name IUPAC, and the year of publication, are prominently visible.Publication of a translation into
another language is subject to the additional condition of prior approval from the relevant IUPAC National Adhering
Organization.

835

M. THOMPSON et al.

836

Harmonized guidelines for single-laboratory
validation of methods of analysis
(IUPAC Technical Report)
Abstract: Method validation is one of the measures universally recognized as a
necessarypart of a comprehensive system of quality assurance in analytical chemistry. In the past, ISO, IUPAC, and AOAC International have cooperated to produce agreed protocols or guidelines on the “Design, conduct and interpretation of
method performance studies” [1], on the “Proficiency testing of (chemical) analytical laboratories” [2], on “Internal quality control in analytical chemistrylaboratories” [3], and on “The use of recovery information in analytical measurement”
[4]. The Working Group that produced these protocols/guidelines has now been
mandated by IUPAC to prepare guidelines on the single-laboratory validation of
methods of analysis. These guidelines provide minimum recommendations on
procedures that should be employed to ensure adequate validation of analytical
methods.A draft of the guidelines has been discussed at an International Symposium
on the Harmonization of Quality Assurance Systems in Chemical Laboratory, the
proceedings from which have been published by the UK Royal Society of
Chemistry.
CONTENTS
1. INTRODUCTION
1.1 Background
1.2 Existing protocols, standards, and guides
2. DEFINITIONS AND TERMINOLOGY
2.1 General
2.2 Definitions used inthis guide only
3. METHOD VALIDATION, UNCERTAINTY, AND QUALITY ASSURANCE
4. BASIC PRINCIPLES OF METHOD VALIDATION
4.1 Specification and scope of validation
4.2 Testing assumptions
4.3 Sources of error in analysis
4.4 Method and laboratory effects
5. CONDUCT OF VALIDATION STUDIES
6. EXTENT OF VALIDATION STUDIES
7. RECOMMENDATIONS
APPENDIX A: NOTES ON THE REQUIREMENTS FOR STUDY OF METHOD...
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