Project Details:

Preparation and harmonisation of guidelines for in-house method validation

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 WorkshopProceedings have been edited by A. Fajgelj and A. Ambrus, and publishedby the Royoal Society of Chemistry (2000). This Volume also includesthe 'Guidelines for Single-Laboratory Validation of Analytical methodsfor Trace-level Concentrations of Organic Chemicals' elaboratedby the AOAC/FAO/IAEA/IUPAC Expert consultation with the participationof 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 Commissionon Agrochemicals and the Environment (VI.4) will be initiated toidentify the areas where further work is required and formulate specificrecommendations.

Harmonised/general guidelines for the in-house validation of methodsof analysis are being prepared as part of Project 501/8/97.

> View Project page, includingdraft report

• Ambrus, Árpad
• Fajgelj, Ales