The term of 'measurement uncertainty' is reinforced in the new norm ISO
17,025 on the accreditation of analytical control and calibration
laboratories, which takes the place of the former EN 45001.
Even though this new ISO norm is less
relevant for the pharmaceutical industry and in addition the term of
'measurement uncertainty' is being used within the pharmaceutical industry
mainly in the field of calibration, it is certainly interesting to find
specific literature on this topic - above all if it can be accessed
directly on the Internet.
There is, for example, the nine-page
publication 'The
Expression of Uncertainty in Quantitative Testing' of the European
Cooperation for Accreditation of Laboratories (DAR-EM25, formerly EAL-G23, 1998) or the
eight-page publication 'Uncertainty
of test results (Result Uncertainty)'
(DAR-EM22). Both can be found on the website of the German
Accreditation Council (DAR) at http://www.dar.bam.de/indexe.html/,
which is available in German and in English.
Detailed information can also be found in
the EURACHEM/CITAC Guide 'Quantifying Uncertainty in Analytical
Measurements' at http://www.eurachem.ul.pt/.
This 120-page guide serves as interpretation of the 'ISO Guide
to the Expression of Uncertainty in Measurements.' By the way, from the
same website you can download the comprehensive EURACHEM Guide with the
title 'The Fitness for Purpose of Analytical Methods, a
Laboratory Guide to Method Validation and Related Topics,' which is very
informative!
Measurement uncertainty is very important
in the pharmaceutical laboratory also in connection with reference
substances. At the international conference 'Reference Standards'
of the European Compliance Academy, which takes place from 29-30 November
2001 in Berlin, a separate lecture is dedicated to this topic, and
certainly the consequences of measurement uncertainty for the reference
substances of the pharmacopoeias (Ph.Eur. and USP) will be discussed.
Writer:
Dr Günter Brendelberger,
CONCEPT HEIDELBERG
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