14/15 July 2020
GMP News No. 128
21 August 2001
The term of 'measurement uncertainty' is reinforced in the new norm ISO17,025 on the accreditation of analytical control and calibrationlaboratories, which takes the place of the former EN 45001.
Even though this new ISO norm is lessrelevant for the pharmaceutical industry and in addition the term of'measurement uncertainty' is being used within the pharmaceutical industrymainly in the field of calibration, it is certainly interesting to findspecific literature on this topic - above all if it can be accesseddirectly on the Internet.
There is, for example, the nine-pagepublication 'TheExpression of Uncertainty in Quantitative Testing' of the EuropeanCooperation for Accreditation of Laboratories (DAR-EM25, formerly EAL-G23, 1998) or theeight-page publication 'Uncertaintyof test results (Result Uncertainty)'(DAR-EM22). Both can be found on the website of the GermanAccreditation Council (DAR) at http://www.dar.bam.de/indexe.html/,which is available in German and in English.
Detailed information can also be found inthe EURACHEM/CITAC Guide 'Quantifying Uncertainty in AnalyticalMeasurements' at http://www.eurachem.ul.pt/.This 120-page guide serves as interpretation of the 'ISO Guideto the Expression of Uncertainty in Measurements.' By the way, from thesame website you can download the comprehensive EURACHEM Guide with thetitle 'The Fitness for Purpose of Analytical Methods, aLaboratory Guide to Method Validation and Related Topics,' which is veryinformative!