The elements and principles provided in ICH Q12 guidance (Technical and regulatory considerations for pharmaceutical product lifecycle management) outline a means to facilitate the management of post-approval chemistry, manufacturing, and controls (CMC) changes in regulatory submissions of new and marketed products. The Q12 guidance builds on the expectation that quality systems will be managed effectively to support and improve the process across the pharmaceutical product life cycle. This rapid-fire discussion identifies key considerations in ICH Q12. This discussion reviews opportunities and challenges of using Established Conditions (ECs) to accelerate post approval changes. It also includes how post-approval change management protocols (PACMPs) align with ECs.
Learning Objectives:
Upon completion, participant will be able to identify key considerations in ICH Q12, describe opportunities and challenges of using established conditions and understand how PACMPs interact with ECs.