Annex 1 compliance remains a key priority for companies working in sterile drug product manufacturing. But recognizing how fundamentally expectations around sterility assurance have changed may be the most significant challenge companies face.
Revisions to the EU GMP Annex 1 requirements now move beyond individual compliance activities and place greater emphasis on how contamination risks are identified, managed and continuously monitored throughout a product’s lifecycle.
What was once viewed as a collection of quality procedures now requires a far more connected and proactive approach.
As regulatory expectations continue to evolve, organizations must consider whether their contamination control strategies are keeping pace. Is compliance enough, or are regulators now looking for something more?
In a recent Pharmaceutical Technology article, Melanie Cerullo, Chief Quality Officer & Head of Regulatory Affairs at Kindeva, explores how Annex 1 is reshaping expectations for sterile manufacturing services and what this shift could mean for pharmaceutical and biotechnology companies.
Read the full article below to learn more: https://www.pharmtech.com/view/trends-in-manufacturing-ebook-may-2026
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