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Analytical Chemistry Division (V)


Number: 501/8/97

Title: Protocol for In-house Method Validation

Coordinator(s): R. Wood, M. Thompson and A. Fajgelj

Remarks: Interest for cooperation already expressed by Division VII, Clinical Chemistry Section. Co-operation with EURACHEM foreseen.

Completion Date: 2002 - project completed

It is generally recognized that in some sectors of analytical chemistry the methods of analysis used should be fully validated, i.e. have been subjected to a collaborative trial. There are, however, many situations where this is not feasible or such methods are not available. As a result the need for laboratories to develop and use their own in-house methods of analysis is well recognized in the analytical community. Until recently such in-house method validation has been undertaken on an ad hoc basis. It has become recognized that such validation should be carried out on more formal basis and a number of organizations have developed procedures and protocols which meet such needs. The Codex Alimentarius Commission has agreed in June 1997 that the topic should be included in its formal work Programme. In particular, it is recognized within the Codex system that there are some sectors of food analysis, e.g. the veterinary residues in food sector, where fully validated methods practically do not exists and it is very unlikely that they will become available. The objective of this project is to bring together the different approaches and to make definitive recommendations as to the "best practice". These would be in the form of a Protocol developed under the auspices of IUPAC and that would be adopted and used by various standardization organizations, governments and regulatory bodies.

Project is ongoing. After being completed, the document will be circulated to WP members and other IUPAC Divisions for comments. As a part of the project, an international workshop on "Principles and Practices of Method Validation" was organized together with the IUPAC Commission on Agrochemicals and the Environment (VI.4). External cooperation organizations are FAO/IAEA Joint Division and AOAC Int. The workshop took place between November 4 to 6, 1999, Budapest, Hungary. After international discussion and approval, the document will be submitted for publication in PAC.

> read Workshop Report - Proceedings
> download a draft of a Technical Report entitled 'Harmonised guidelines for the in-house validation of methods of analysis' - pdf 139KB

Project completed - IUPAC Technical Report published in Pure Appl. Chem. 74(5), 835-855, 2002.

Last update: 27 June 2002

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Page last modified 27 June 2002.
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