3 - Global Regulatory Frameworks and cGMP (S13E3)

18 min • 10 maj 2025

Venture beyond national borders to explore the diverse and interconnected global regulatory landscape that shapes cGMP practices worldwide. This episode compares and contrasts major regulatory agencies, such as the FDA in the United States and the EMA in Europe, highlighting their similarities and differences in expectations. We'll delve into the role of the International Council for Harmonisation (ICH) in striving to create a unified, global framework for GMP, promoting consistency and collaboration across different regions.

Understand how these international standards interrelate and harmonize, ultimately ensuring the safety and quality of pharmaceutical products, regardless of where they are manufactured or consumed. Examine the challenges faced by multinational companies navigating this complex web of regulations and consider how global best practices are integrated into local inspections and compliance strategies. Explore real-world examples, discuss the importance of audits, and highlight the critical role of technology in shaping the future of global GMP compliance.