Lori McCaig, Steven Nowak, Alexander Abbott, Jenny Carhart, Megan E McMahon, Elke Debie, Hanlin Li, Francis Maina, Andrea J Ji, Mingkun Fu, Yan Wu, Andrew Lennard, Tony Mazzeo, Chad Wolfe, Robert Timpano, Yelizaveta Babayan, Lars Gruenig
ICH Q12 asserts that science- and risk-based approaches are applicable to stability studies supporting Chemistry, Manufacturing and Controls (CMC) post-approval changes (PAC) to enable more timely implementation; however, no guidance or specific examples are provided to demonstrate how prior knowledge of the product can inform the risk assessment for the proposed change(s). Ten diverse case studies are presented in this manuscript to demonstrate how science- and risk-based stability strategies were used to support drug substance and product CMC PAC and lifecycle management activities...
March 14, 2024: AAPS Journal