ICH Q12 Implementation: Regulatory Intelligence And Post Approval Change Management (PACM) Agility

Published in 2019, ICH Q12 aims to provide tools and a structured approach to improve flexibility for post-approval changes of commercial products. Building on ICH Q8, Q9, Q10, and Q11, it promotes continuous improvement, innovation, and an accelerated drug product supply to market.

By defining critical product quality information in regulatory submissions and adopting a science- and risk-based approach, companies can better manage the inevitable changes throughout the product lifecycle. Embracing change can lead to improved product quality and economics and foster innovation. As companies navigate change management, they will enhance their knowledge and promote a quality culture, enabling continuous process and product improvement from the early stages of a product to its discontinuation.

This article integrates ICH Q12 concepts into a framework to help companies implement ICH Q12 from day one and realize its benefits early on. Learn how digital platforms can streamline the ICH Q12 framework application and how digitalization provides the scalability necessary to apply this framework broadly within an organization.