European Commission — EudraLex
The European Commission publishes the EU GMP guidelines. It does not inspect sites — that is done by the national competent authority of each member state.
Source library
Start with the source
Most GMP content online is a paraphrase of a paraphrase. This library connects practical explanation to the authoritative text, and keeps the two visibly separate so it is always clear which you are reading.
The rule
Official source on one side, our explanation on the other, never blended. Every link here was checked to resolve, and every page tells you to verify current status at the authority before acting.
European Union
The binding framework for manufacture and import in the EU.
European Medicines Agency
EMA coordinates GMP inspection activity across member states and issues scientific guidelines. It does not issue manufacturing authorisations — national competent authorities do.
Netherlands
National inspectorate and medicines authority.
Inspectie Gezondheidszorg en Jeugd
IGJ carries out GMP inspections of manufacturers in the Netherlands. Marketing authorisation is a separate matter, handled by CBG-MEB.
International
Harmonised guidance adopted across many regulators.
Pharmaceutical Inspection Co-operation Scheme
PIC/S is a co-operative arrangement between inspectorates. It is not a regulator and issues no authorisations; its guidance is adopted by participating authorities.
International Council for Harmonisation
ICH produces harmonised guidelines adopted by regulators. It is not itself a regulator and does not inspect or authorise.
United Kingdom
Relevant post-Brexit for UK supply.
Medicines and Healthcare products Regulatory Agency
MHRA is the UK regulator. Its guidance is not binding in the EU, but its data integrity material is widely used as a reference on the substance of the requirements.
United States
Relevant where product is supplied to the US market.
Food and Drug Administration
FDA regulates medicinal products for the US market. Its requirements apply to EU sites exporting there, in addition to EU GMP.
Limits
What this library is, and is not
GMPConsultant.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.
Next step
From the source to your own position
The knowledge base explains where each requirement goes wrong in practice; the Health Index turns that into a scored position across seven domains.