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.

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.