EU-GMP (EudraGMDP)
Issued by European Medicines Agency (EMA) + national competent authorities (e.g., MHRA UK, AIFA Italy, ANSM France)
CertificationAudit Scope
EU-wide Good Manufacturing Practice for MEDICINAL products + active pharmaceutical ingredients per Directive 2003/94/EC and Eudralex Vol. 4. EMA-coordinated inspections; cert published in EudraGMDP database. Region-specific to EU regulatory framework.
What It Proves
Facility holds a current EU-GMP certificate published in EudraGMDP database for MEDICINAL product manufacturing. Inspection conducted by an EU competent authority; cert valid 3 years.
What It Does Not Prove
Scope is MEDICINAL (pharmaceuticals + APIs), NOT dietary supplements. For ingredient suppliers serving the US supplement market, EU-GMP is a strong signal of manufacturing quality but does NOT substitute for category-appropriate certs (FSSC 22000, BRC Food Safety, ISO 22000 for food-grade ingredient supplier; FDA cGMP per 21 CFR 111 for finished supplements). EU-GMP for a supplement-only ingredient supplier may indicate dual-use medicinal-grade production OR may not apply at all.
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