Grasas y Aceites, Vol 53, No 1 (2002)

Validation of analytical methods


https://doi.org/10.3989/gya.2002.v53.i1.295

Ricard Boqué
Department of Analytical Chemistry and Organic Chemistry. University Rovira i Virgili, Spain

Alicia Maroto
Department of Analytical Chemistry and Organic Chemistry. University Rovira i Virgili, Spain

Jordi Riu
Department of Analytical Chemistry and Organic Chemistry. University Rovira i Virgili, Spain

F. Xavier Rius
Department of Analytical Chemistry and Organic Chemistry. University Rovira i Virgili, Spain

Abstract


In this paper we shall discuss the concept of method validation, describe the various elements and explain its close relationship with fitness for purpose. Method validation is based on the assumption that a series of requirements are fulfilled and we shall explain how these requirements are selected, the way in which evidence is supplied and what work has to be carried out in the laboratory. The basic principles of method validation and the different ways to validate a methodology, by inter-laboratory comparison or performing an in-house validation, are also described.

Keywords


Fitness-for-purpose; In-house validation; Method validation; Performance criteria

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