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Analytical Chemistry Division (V)


Number: 1999-006-1-500 [ 5/2/99 ]

Title: Preparation and harmonisation of guidelines for in-house method validation

Coordinator(s): A. Fajgelj and A. Ambrus

Remarks: Joint project FAO-IAEA-AOAC-IUPAC

Completion Date: 2000

The objective of the project is to prepare and harmonise guidelines for "in-house validation" of analytical methods, that is, methods developed and validated in the same laboratory. Toward this aim, general guidelines will be prepared, as well as more specific ones on methods for determination of pesticide and veterinary drug residues. Harmonisation of the guidelines among IUPAC, ISO, FAO/IAEA, AOAC International, EURACHEM, etc., is foreseen. As such, the project should result in the publication of two separate internationally harmonised documents that can be followed by laboratories in their daily work as well as by the certification or accreditation bodies assessing those laboratories.

The most important milestone is the Workshop planned in Budapest, 4-6 November 1999. For more information, see Workshop Homepage.
> read Workshop Report

The Workshop Proceedings have been edited by A. Fajgelj and A. Ambrus, and published by the Royoal Society of Chemistry (2000). This Volume also includes the 'Guidelines for Single-Laboratory Validation of Analytical methods for Trace-level Concentrations of Organic Chemicals' elaborated by the AOAC/FAO/IAEA/IUPAC Expert consultation with the participation of L. Alder, A. Hill, P.T. Holland, J. Lantos, S.M. Lee, J.D. MacNeil, J. O'Rangers, P. van Zoonen, and A. Ambrus.

Guidelines Contents:

  • Overview
  • Table 1. Summary of parameters to be assessed for method validation
  • Table 2.Within laboratory performance criteria for quantitative organic trace analysis
  • Table 3. Suitability of detection of substances at trace levels
  • Fig 1. Overview of Method Validation
  • Fig 2. Verification of Analyte Stability
  • Annex 1. Method validation for pesticide resdues
  • Annex 2. Method validation for residues of veterinary drugs
  • Annex 3. Worked example of method validation, as applied to a method for pesticides residues
  • Annex 4. Statistical methods applicable to validation of analytical methods
  • Annex 5. Glossary and list of abbreviations
  • Annex 6. Development of principles for assuring reliability of analytical results

A follow up project within the Commission on Agrochemicals and the Environment (VI.4) will be initiated to identify the areas where further work is required and formulate specific recommendations.

Harmonised/general guidelines for the in-house validation of methods of analysis are being prepared as part of Project 501/8/97.
> View Project page, including draft report


Last update: 3 November 2000 - project completed


Page last modified 3 November 2000.
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