EU GMP Annex 1: Non-Viable Environmental And Process Monitoring Insights And Updates

By Frank Panofen, Ph.D., Maurizio Della Pietra, Daniele Pandolfi, Anna Campanella, Giulia Artalli, And Paola Lazzeri

The 2020 release of the EU GMP Annex 1 draft includes a new chapter on viable and non-viable environmental and process monitoring. Trend analysis and its impact on the contamination control strategy is now an essential activity referenced multiple times. There is also clear differentiation between qualification and monitoring, and quality risk management concepts are interwoven into each section.

Continue reading to learn more about the new EU GMP Annex 1 topics including system design, monitoring, cleaning and disinfection, risk assessment, microflora, events and deviations.