Module232025

cGMP and REGULATORY COMPLIANCE … are indispensably connected (by Quality Risk Mgmt)

Local site manufacturing and quality operations and Supply Chain

Market and Patient

Regulatory

cGMP

“The key focus is on ‘Phase -appropriate QMS operations and compliance. ’ Additionally, robust prior process and product knowledge is fundamental to enabling science-driven risk management and justifications throughout the critical pathway — from early R&D, through clinical trial material (CTM) stages, to commercial launch. Therefore, integrating cGMP compliance into R&D is essential to prevent costly and time-intensive setbacks, ensuring seamless transitions between development phases. ”

Quality (CMC) Development Considerations

The Organisation for Professionals in Regulatory Affairs