Method Validation and Sample Analysis in a Controlled Laboratory Environment

Method Validation and Sample Analysis in a Controlled Laboratory Environment 

Definitions of the basic concept of validation can vary from single fine sentences to much longer descriptions. Here one of the longer descriptions is quoted (Thompson 2002) since it appears that it better addresses the complexity of the real situation at the expense of some measure of perceived elegance . 

Trace Quantitative Analysis by Mass Spectrometry Robert K. Boyd, Cecilia Basic, Robert A. Bethem 2008 John Wiley Sons, Ltd. ISBN 978-0-470-05771-1 

Elucidation of how the general principles underlying the concept of validation should be expressed in practice is an evolving process, as exemplified by the ongoing evolution of validation requirements for bioanalytical assays in the pharmaceutical industry (Shah 1992, 2000 FDA 2001 Viswanathan 2007). The complementary principle of fitness for purpose (Section 9.2) applies not only to the assay method but also to the validation process itself. Procedures that are considered to be fit for purpose in validation of an analytical method to be used in drug development, for example, need not necessarily apply to, e.g., methods used to screen pesticide residues in foodstuffs. As noted in Section 9.2, this point of view appears to be consistent with the definition of validation applied to all measurements (ISO 1994) Validation Confirmation by examination and provision of objective evidence that the particular requirements for a specified intended use are fulfilled. Of course, some basic principles are common to all validation schemes. 

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