Analytical Method Validation for Biopharmaceuticals

Abstract

Analytical method validation (AMV) is required in the biopharmaceutical industry for all methods used to test final containers (release and stability testing), raw materials, in-process materials, and excipients. 1 AMV is also required for test methods that are used to validate the process prior to process validation. This article reviews current regulatory guidelines and the critical elements of analytical method development (AMD) that should be finalized before starting AMV.