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