By Josh Chu, Chemist, Bora Pharmaceuticals
To submit a filing to the FDA, whether that be an NDA, ANDA, or 505(b)(2), a product owner must provide technical files containing a pharmaceutical product's chemistry, manufacturing, and control (CMC), safety (nonclinical), and efficacy (clinical) testing results before gaining approval and market access. This includes analytical testing procedures for the drug substances and the finished product. These analytical testing methods must meet certain standards to ensure product safety and efficacy through the life of the product.
These standards of reliability and accuracy must be maintained through the site-to-site technology transfer of the product. One of the key elements of any technology transfer is to figure out the analytical scope of work to minimize site-to-site and lot-to-lot variability. For a contract manufacturer, one of the first steps in evaluating a technology transfer project is: do we need to perform analytical method verification or method validation? Although method verification and method validation look similar, they are really not the same and have different requirements. It is important to distinguish these two terms, as they are GxP requirements to assure that the product quality is based on the guidelines of pharmaceutical industry, such as United States Pharmacopeia (USP) and International Conference on Harmonisation (ICH). To understand the difference between these two terms, let us start with the definition.