In this in-depth focus, explore how automation is transforming environmental monitoring in line with Annex 1, implementation of contamination control strategies and discover the emerging trends and challenges in pharmaceutical microbiology.
Leveraging PAT for environmental monitoring in light of Annex1
The pharma industry’s adaptation to Industry 4.0 has been slow, due to the extensive regulatory requirements imposed on manufacturers. However, regulatory agencies are starting to embrace movement towards more rapid/automated systems, as illustrated in the revised EU GMP Annex 1, which is due to enter into force in August. Here, Isabella Jul-Jørgensen from the Technical University of Denmark and Novo Nordisk delves into advances in rapid and automated environmental monitoring systems.
Uncovering new frontiers in microbiology and EM
In this Q&A, Laure Pomares Voisin, Quality Director, Catalent Biologics and Tony Cundell Principal Consultant, Microbiological Consulting, LLC discuss some of the key microbiology and environmental monitoring challenges and trends in pharmaceutical manufacturing today.
What’s next for microbiology and EM?
A key part of Annex 1, due to come into effect on 25 August 2023, is the development of a holistic contamination control strategy (CCS). In this article, EPR’s Caroline Peachey summarises an expert panel discussion, which explored common challenges in implementing a CCS and made several recommendations.
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