EU GMP Chapter 3 extends compliance beyond cleanrooms. It requires a risk-based approach to facility design driven by Quality Risk Management to prevent cross-contamination, including the use of dedicated facilities where needed. The chapter also highlights the critical role of printed packaging materials and the importance of site design details, all working together to protect patient safety.

EU GMP Chapter 1 transforms the Pharmaceutical Quality System (PQS) from a compliance checklist into a strategic business asset. This article explores 4 core principles: placing ultimate responsibility in the C-Suite, digging deeper than “human error,” extending oversight across the full product lifecycle, and mandating continual improvement. Learn how to evolve your PQS from a cost center into a driver of resilience and operational excellence.