Comparability of biotechnology-derived medicinal products after a change in the manufacturing process - non-clinical and clinical issues - Scientific guideline

This document gives advice on the non-clinical and clinical requirements of the comparability exercise comparing post-change product to pre-change product where manufacturing process changes are made by a single manufacturer, including those made by a contract manufacture. It addresses the requirements for non-clinical and/or clinical bridging studies to demonstrate that the manufacturing change has no impact on safety and efficacy.

Keywords: Comparability testing, changes in manufacturing procedure, non-clinical, efficacy, pharmacovigilance