Control Strategy Global Harmonization Webinar
Join us from 11:00 - 12:00 PM ET on 20 May for the IQ Webinar: Control Strategy Global Harmonization Webinar
KeAndra Robinson, Biogen
Greg Rullo, AstraZeneca
Tim Watson, Pfizer
Tim Graul, Pfizer
Presented by the Control Strategy Global Harmonization Working Group
Sponsored by the IQ Quality Leadership Group
ICH guidelines introduced risk-based approaches and enhanced scientific understanding as an opportunity to encourage continuous process improvement for pharmaceutical manufacturing. Conceptually, Quality by Design (QbD) promised to improve confidence in quality through the lifecycle of pharmaceutical products. A primary incentive for industry is the prospect of global regulatory concordance for new applications and post approval changes. Unfortunately, during the last decade, the industry has experienced a proliferation of regulatory divergence regarding the interpretation of ICH guidelines (and control strategies (CS)) across geographic regions. Rather than truly harmonized regulatory expectations, localized interpretations of ICH guidance have resulted in different technical requirements and/ or control strategies posing significant challenges for a global industry. As a result, the increased complexity of manufacturing supply chains and the regulatory burden associated with maintaining compliance with these diverse regulatory expectations serves as a barrier to continual improvement and innovation. Diverge has become one of the newest risks to continued improvements (disincentive) and risks temporary drug shortages in some markets.
The purpose of this presentation is to share data collected by the IQ Consortium - Control Strategy Global Harmonization Working Group that highlight instances where different regulatory agencies diverge from the ICH guidance in their evaluation of the CTD submitted by industry (same scientific data). The data illustrates where this divergence led to modifications to control strategies, leading to different CS globally, for a product intended for global markets.