Are you trying to understand what is method validation, method verification, and what the difference between the two are? Josh Chu from Bora Pharmaceuticals dives into these two seemingly similar evaluation processes and discusses in detail their distinct definitions and requirements. Learn about different scenarios that warrant the need to perform such evaluation processes and also when these processes are not necessary.
Josh emphasizes the importance of having appropriate and standardized analytical testing methods to ensure drug product safety and efficacy. When conducting analytical testing, many times the first question you will need to ask yourself is whether or not you will need to perform method validation or method verification. These processes are crucial steps and basic requirements when you are seeking approval from regulatory authorities such as the FDA or Health Canada. If you need support, an experienced analyst at a good CDMO/CMO laboratory may help!
Click here to read Josh Chu’s full article.