EMA coordinates rather than inspects. Its practical importance for a manufacturer is the guidance it issues and the EudraGMDP database, where inspection outcomes are published.
EMA coordinates GMP inspection activity across member states and issues scientific guidelines. It does not issue manufacturing authorisations — national competent authorities do.
Official sitePublished by EMA. Verify current status at the source.
EMA's overview of the GMP framework, inspection coordination and the relationship between the Agency and national inspectorates.
Read the full articlePublished by EMA. Verify current status at the source.
Holds manufacturing and importation authorisations, GMP certificates and GMP non-compliance statements. Outcomes here are public, which is why a non-compliance statement carries commercial as well as regulatory consequence.
Read the full articleGMPConsultant.nl is an independent advisory. It is not a regulator, a notified body or a certification body. Explanations on these pages are our interpretation, published separately from the official text so the two are never confused. Always verify against the primary source before acting — guidance is revised, and a page here may not reflect the most recent position.
Knowing what a source says is the start. The Health Index turns it into a scored position across seven domains, and the knowledge base explains where each requirement goes wrong in practice.