Some practical examples of method validation in the analytical laboratory

Abstract Method validation is a key element in both the elaboration of reference methods and the assessment of a laboratory's competence in producing reliable analytical data. Hence, the scope of the term method validation is wide, especially if one bears in mind that there is or at least should be a close relation between validation, calibration and quality control QA/QC. Moreover, validation should include more than the instrumental step only since the whole cycle from sampling to the final analytical result is important in the assessment of the validity of an analytical result. In this article validation is put in the context of the process of producing chemical information. Two cases are presented in more detail: the development of a European standard for chlorophenols and its validation by a full scale collaborative trial, and the intralaboratory validation of a method for ethylenethiourea using alternative analytical techniques.

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