Stimuli Article on Lifecycle Approach to Analytical Methods

Check out “Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification” in Pharmacopeial Forum, 39(5), October, 2013. The article proposes a lifecycle approach for analytical methods, linking method development, validation, verification and transfer by means of an Analytical Target Profile (ATP). The ATP is a relatively new concept, not yet widely accepted, which identifies the requirements for certain analytical performance characteristics to demonstrate the method is suitable for its intended purpose. This approach could have major implications for the future of pharmacopeial methods. USP is seeking comments on this approach.