What Is The Difference Between Method Verification And Method Validation?

Clients have come to us in the past asking "We need 'method validation'.” Sometimes they'll use the term “validation” or “verification” but it seems apparent they're not really clear on what the difference is between the two. For the most part it’s not that well-known that method validation is a much more rigorous process. What’s really needed, more likely, is the establishment of a verification regime that assures analytical methods perform reliably, accurately, and precisely for its intended application.

Method validations are performed for new methods that have just been developed or instituted, and that require revisions because they've been significantly changed. So oftentimes its “re-validation” that is really required in the wake of making significant changes to a method, equipment, or conditions of the analysis. Examples include: changes in the formulation, changes in the instrumentation that’s intended to be used—perhaps chromatographic conditions for each PLC, sample preps, filters, etc.