Three years on: How is the industry coping with Annex 1? - Pharmaceutical Technology

Industry expert Ian Hudson shares his insights into the deeper nuances and practical impact of the revised EU GMP Annex 1. The revised EU GMP Annex 1 shifts the pharmaceutical industry from fragmented compliance to a holistic, comprehensive framework. Industry expert Ian Hudson shares his insights into the deeper nuances and practical impact of these changes. Image: Shutterstock Three years after its release, the revised EU GMP Annex 1 stands as an industry watershed, redefining sterile medicine manufacturing. Navigating this update requires manufacturers to transition from fragmented contamination control procedures toward a holistic, risk-based operational approach to contamination control. Ian…

Source: Pharmaceutical Technology