Inter-laboratory, time, and fitness-for-purpose aspects of effective validation

This paper reviews current approaches to validation of analytical chemical methods. It identifies some shortcomings of existing validation schemes such as insufficient coverage of variability in space or time, and mismatches between validation criteria and intended use of the method, e.g. the use in...

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Bibliographic Details
Published in:Analytica chimica acta 1999-05, Vol.391 (2), p.159-171
Main Authors: van der Voet, Hilko, (Hans) van Rhijn, J.A, van de Wiel, Henk J
Format: Article
Language:English
Subjects:
In-house validation
Internal quality control
Measurement uncertainty
Method performance study
PRI Biodiversiteit en Veredeling
PRI Biodiversity and Breeding
Proficiency testing
Validation
Variance components model
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Summary:This paper reviews current approaches to validation of analytical chemical methods. It identifies some shortcomings of existing validation schemes such as insufficient coverage of variability in space or time, and mismatches between validation criteria and intended use of the method, e.g. the use in regulatory control. A general statistical modelling approach for combining different aspects of validation is recommended, and illustrated with an example. This type of modelling, based on components of variation, is advocated as the basis for the development of new statistically underpinned validation schemes which integrate current validation and quality assurance activities.
ISSN:0003-2670
1873-4324
DOI:10.1016/S0003-2670(99)00109-9