EU GMP

EudraLex Volume 4 is the guideline document, and its structure matters because it determines which rules apply to you. Part I covers medicinal products and is organised as nine chapters. Part II covers active substances used as starting materials and is essentially ICH Q7. Part III holds supporting documents rather than requirements — the Site Master File format, ICH Q9 and ICH Q10 among them. The Annexes then layer product- or activity-specific requirements on top.

The guideline itself is not the law. Legal force comes from the Directives: Directive 2001/83/EC establishes the framework for medicinal products for human use, Commission Directive (EU) 2017/1572 sets out the GMP principles and guidelines for them, and Commission Delegated Regulation (EU) 2017/1569 does the equivalent job for investigational medicinal products. This is why 'it is only a guideline' is a misreading.

Enforcement is national. Each member state's inspectorate inspects sites in its territory and issues GMP certificates or non-compliance statements, which are published in the EudraGMDP database. EMA coordinates rather than inspects. For a Dutch site the inspectorate is IGJ; marketing authorisations are a separate matter handled by CBG-MEB.

Two practical consequences follow. First, an inspection outcome in one member state is visible across the EU and to your customers. Second, PIC/S membership means the same expectations largely travel — a PIC/S-aligned inspectorate outside the EU will recognise the same structure, which is why the EU text is worth knowing even for sites supplying elsewhere.