Cole and Jaenisch dig into AI poisoning in pharma manufacturing, how it hides in plain sight, and who should be accountable for catching it.
News|Articles|October 17, 2025
Most frequently asked question on the revised EU GMP Annex 1 – Volume 1
Author(s)West Pharma
This article answers key questions about the revised EU GMP Annex 1, which sets stricter standards for sterile drug manufacturing, including contamination control strategies, personnel training, and the use of modern barrier technologies like RABS and isolators. It explains the rationale behind the revision, its impact on both new and marketed drugs, and how manufacturers must adapt to meet heightened regulatory expectations.
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