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Practical method validation: Validation sufficient for an analysis method

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Abstract

Validation of an analysis method depends on the purpose of the method, the chosen technique and the procedure in question. Methods are used for different research, product development, process control and quality control purposes. The human and economical importance of results vary. Each of the techniques used, such as chromatography-(HPLC, HRGC, TLC), capillary electrophoresis-(CE), spectrophotometry-(UV/VIS, IR, fluorescence, AAS, ICP) or spectrometric techniques (NMR, MS) as well as the hyphenated methods, have their own special features and deficiencies which must be considered. The method can include a simple pretreatment or it may include many demanding steps, it can use automation and data processing in various ways, it can have an official status, it can be a thoroughly verified or less studied one. How should these differences be accounted for during the validation? What would be a sufficient certainty that the method does what is expected, that the method fits for the purpose it was intended?

The client (or authority) decides the required timetable, cost and quality level. This is why within a laboratory different quality levels and associated levels of validation exist. This paper tries to outline a practical test frame for validation efforts to assist the analyst when planning validation of a method.

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Author notes

  1. P. Bruce

    Present address: OPCW/PTS, Lan van der Merdervoort, 2517, AE The Hague, The Netherlands

Authors and Affiliations

  1. Technology Center, Cultor Ltd., SF-02460, Kantvik, Finland

    P. Bruce

  2. Lappeenranta University of Technology, P.O. Box 20, FIN-53851, Lappeenranta, Finland

    P. Minkkinen

  3. Department of Chemistry, University of Helsinki, P.O. Box 55, FIN-00014, Helsinki, Finland

    M. -L. Riekkola

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  1. P. Bruce
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  2. P. Minkkinen
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  3. M. -L. Riekkola
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Bruce, P., Minkkinen, P. & Riekkola, M.L. Practical method validation: Validation sufficient for an analysis method. Mikrochim Acta 128, 93–106 (1998). https://doi.org/10.1007/BF01242196

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