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In this episode, we break down EU GMP Annex 1: Manufacture of Sterile Medicinal Products. You'll learn why Annex 1 is critical for sterile drug manufacturing, what changed in the latest revision, and how these updates impact cleanroom design, contamination control strategies, and risk-based approaches. We also talk about practical steps manufacturers need to take to stay compliant. Whether you're in QA, production, or regulatory affairs, this episode gives you the clarity you need on Annex 1.
By Dr. Mohamad ToutounjiIn this episode, we break down EU GMP Annex 1: Manufacture of Sterile Medicinal Products. You'll learn why Annex 1 is critical for sterile drug manufacturing, what changed in the latest revision, and how these updates impact cleanroom design, contamination control strategies, and risk-based approaches. We also talk about practical steps manufacturers need to take to stay compliant. Whether you're in QA, production, or regulatory affairs, this episode gives you the clarity you need on Annex 1.