Method Validation

Purpose of Method Validation

The purpose of method validation is to demonstrate that the established method is fit for the purpose. This means that the method, as used by the laboratory generating the data, will provide data that meets the criteria set in the planning phase. There is not a single accepted procedure for conducting a method validation. Much of the method validation and development are performed in an iterative manner, with adjustments or improvements to the method made as dictated by the data. The analyst's primary objective is to select an approach that will demonstrate a true validation while working in a situation with defined limitations, such as cost and time.

Analysts often wonder if a published 'validated method' must be validated in their own laboratory. It is considered unacceptable for the analyst to use a published 'validated method' without demonstrating their capability in the use of the method in their laboratory. This does not mean, however, that the analyst must repeat the original validation study. It is therefore important for the analyst to be familiar with the method validation process to enable the selection of the validation approach that's appropriate for the situation.

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