Symposium 2025 Recordings

Regulatory Considerations for Pharmaceutical Manufacturing Process Models

Dr. Ben Stevens

Abstract

The integration of process models into pharmaceutical manufacturing has gained considerable attention in recent years due to their potential to enhance efficiency, productivity, and quality control. With the growing interest in the application these models to regulated products and processes, regulators and industry alike have weighed the risks and benefits of this technology and begun to formulate general approaches to ensure their safe and effective use. Early initiatives, such as FDA’s FRAME and the EMA Quality Innovation Group (QIG) Listen and Learn Focus Groups (LLFG) have begun to collect information from industry stakeholders and define specific CMC considerations, although guidance is limited at this time. A recent QIG concept paper has been instrumental in offering insight into the current thinking of EMA regulators.

This presentation will highlight some recent GSK case studies that rely process models, providing context within the evolving regulatory landscape. An industry perspective of the perceived hurdles for broader implementation and use will be presented. Existing guidance and technical definitions will be presented. The discussion will address critical elements these models such as model risk (impact), performance, validation, regulatory registration and lifecycle management, and aspects of GMP compliance. We will share feedback and experience from recent regulatory interactions. Next steps will be proposed and used to catalyze further audience engagement and feedback.