INTERDIVISIONAL
WORKING PARTY ON HARMONIZATION OF QUALITY ASSURANCE
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
Objective:
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.
Progress:
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