Analytical Method Validation When to use Any time the question is whether an analytical procedure is fit for its intended purpose: designing a validation study, evaluating validation data, verifying a compendial procedure, transferring a procedure to another laboratory or instrument, or defending any of these in a report. The two rules 1. Establish which framework governs before designing anything. The same assay validates differently under ICH Q2(R2), USP <1225 , ICH M10, CLSI EP, and ISO/IEC 17025. They differ in which characteristics are required, how the studies are laid out, and whether…