Review of Annex 1 2022: Environmental Monitoring Changes
The long-anticipated revisions to EU GMP Annex 1 have officially been implemented, leaving many manufacturers navigating the complexities of compliance. To help you stay ahead, Particle Measuring Systems (PMS) has enlisted two of our leading experts to clarify the updated environmental monitoring requirements, provide practical solutions, and answer your most pressing questions.
With a shift toward strategic control rather than simple quality measurement, the latest Annex 1 emphasizes Quality by Design (QbD) and a risk-based approach. This interconnected strategy ensures that cleanroom classifications are maintained and that environmental monitoring is directly aligned with product protection.
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How the Annex 1 layout has evolved for controlled environments
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Key changes in cleanroom classification
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New and enhanced approaches to cleanroom monitoring
Don’t miss this opportunity to strengthen your contamination control strategy and stay fully compliant in 2025.