Insight into the New EU GMP Annex 1

Abstract

The 2020 release of the EU GMP Annex 1 draft includes a new chapter on viable and non-viable environmental and process monitoring. The contamination control strategy and its dependence on trend analysis, process understanding, thorough investigation, and a commitment to progress is now an essential activity referenced multiple times through the document. There is also clear differentiation between qualification and monitoring, and quality risk management concepts are critical to successful implementation of system controls.