Validation of an analytical procedure is the process by which it is established, by laboratory studies, that the performance characteristics of the procedure meet the requirements for its intended use. All analytical methods that are intended to be used for analyzing any clinical samples will need to be validated. The objective of validation of an analytical method is to demonstrate that the procedure, when correctly applied, produces results that are fit for purpose. Validation of analytical methods is an essential but time - consuming activity for most analytical development laboratories. It is therefore important to understand the requirements of method validation in more detail and the options that are available to allow for optimal utilization of analytical resources in a development laboratory. In this article the method validation process and the minimum requirements to be included in a regulatory method are discussed. Also a comparison between various parameters have been made i.e. in ICH, Pharmacopoeia & FDA. This article presents a discussion of the characteristics for consideration during the validation of the analytical procedures included as part of registration applications to be submitted.
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