Comparability Protocol

A comparability protocol is a comprehensive, prospectively written plan that outlines the assessment process for evaluating the impact of a proposed post-approval change in the Chemistry, Manufacturing, and Controls (CMC) of a drug product or biological product. The purpose of the comparability protocol is to ensure that any changes made to the product’s CMC do not adversely affect its identity, strength, quality, purity, and potency.

The comparability protocol plays a critical role in the pharmaceutical industry, ensuring that any post-approval changes to drug products or biological products are thoroughly evaluated and do not compromise their safety, quality, or efficacy. It reflects a proactive approach by manufacturers to maintain product consistency and ensure patient safety throughout the product’s lifecycle.