What EU GMP Annex 1 - Manufacture of Sterile Medicinal Products (2022) requires
This regulation requires manufacturers of sterile medicinal products to implement a contamination control strategy, as outlined in Article 17 of the EU GMP Guidelines, and to maintain a cleanroom environment that meets the standards specified in Article 32.
Pillar: Pharmaceuticals & Life Sciences · Authority: European Commission · Version: 1.0.1 · Last updated:
Primary source: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
SHA-256 integrity: 22aa23462d3cfcd9c4612d1c1586effaee6aaba45eab1264003d98192dc083e9
Primary Citations — 5 traced to source
- EU GMP Annex 1, Article 17 - Contamination Control Strategy
- EU GMP Annex 1, Article 32 - Cleanroom Classification
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