Supplier Qualification & Due Dilige

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.

EMA GACP Revision 1 modernizes Good Agricultural and Collection Practice for today’s medical cannabis operations, with a specific focus on indoor cultivation controls. This article explains what GACP is, why it is the starting point for pharmaceutical supply chains, and how it connects to GMP expectations. It highlights the most relevant updates for cultivators, including Annex 1 requirements for controlled environments, the need to define Critical Quality Attributes.