INTERDIVISIONAL WORKING PARTY ON HARMONIZATION OF QUALITY ASSURANCE
Harmonized guidelines for single-laboratory validation of methods
of analysis (IUPAC Technical Report)
Michael Thompson1, Stephen L. R. Ellison2, and
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
Abstract: Method validation is one of the measures universally
recognized as a necessary part 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" , on the "Proficiency testing of (chemical) analytical
laboratories" , on "Internal quality control in analytical
chemistry laboratories" , and on "The use of recovery information
in analytical measurement" . 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
** Corresponding author.
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