170135_inorganicventures_flipping

17.2 Method Validation

Purpose of Method Valida2on :

• The purpose of method valida3on is to demonstrate that the established method is fit for the purpose. • This means that the method, as used by the laboratory genera3ng the data, will provide data that meets the criteria set in the planning phase. • There is not a single accepted procedure for conduc3ng a method valida3on. • Much of the method valida3on and development are performed in an itera3ve manner, with adjustments or improvements to the method made as dictated by the data. • The analyst's primary objec3ve is to select an approach that will demonstrate a true valida3on while working in a situa3on with defined limita3ons, such as cost and 3me.

17.3 Method Validation

Purpose of Method Valida2on : (cont.)

• Analysts o/en 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 demonstra>ng their capability in the use of the method in their laboratory. • This does not mean, however, that the analyst must repeat the original valida>on study. • It is therefore important for the analyst to be familiar with the method valida>on process to enable the selec>on of the valida>on approach that's appropriate for the situa>on.