EU GMP, Eudralex Volume 4: what it is, who needs to comply, and how inspection works

What is EU GMP?

EU GMP is the good manufacturing practice the European Commission publishes as Volume 4 of Eudralex, for medicinal products for human and veterinary use. Part I holds the basic requirements for medicinal products in nine chapters. A manufacturer complies with it under its manufacturing authorisation, and the member state's competent authority inspects the site and issues a GMP certificate.

The nine chapters of Part I are the pharmaceutical quality system, personnel, premises and equipment, documentation, production, quality control, outsourced activities, complaints and product recall, and self inspection. The Commission revises them one at a time, and Chapter 1 was rewritten around ICH Q10 in 2013. Volume 4 is guidance under Directive 2001/83/EC and the GMP directive made beneath it, which replaced Directive 2003/94/EC. No certification body certifies against it. The GMP certificate is the competent authority's, issued after inspection.

Who needs to comply with EU GMP?

Every holder of a manufacturing or import authorisation in the EU or EEA, for human or veterinary medicinal products, since the authority grants it on condition the site complies with GMP

Manufacturers outside the EU whose products are imported into it, since the importer's Qualified Person has to re-test each batch in the EU unless a mutual recognition agreement stands in, and the importer has to verify the site works to EU GMP

Contract manufacturers, packagers and laboratories that do outsourced work under Chapter 7, and the contract giver who stays responsible for it through the written contract

The guidelines become urgent when the competent authority gives notice of the inspection, when the Qualified Person will not certify a batch until the deviation on it is closed, or when a CDMO's technical agreement arrives and says which chapters are yours.

EU GMP IN QUALIO

Qualio assesses the same records against Eudralex beside 21 CFR 211, so the EU inspector and the FDA investigator read the same procedures

Qualio breaks Eudralex Volume 4 down chapter by chapter, beside 21 CFR 211, and maps your procedures, deviations, change controls and supplier files to the chapters they answer. When a record changes, it reassesses the chapters that record touches and recommends a fix for each gap. Copilot drafts the deviation write-up from it, and your team approves it. When the inspector asks, you export the evidence by chapter.

A procedure or process change routed to the approvers your procedure names, effective on the date you set, with the retraining out that day to everyone who follows it, for Chapters 2 and 4

Contract manufacturers and laboratories qualified once, with an audit schedule set by risk and every deviation linked to the supplier behind it, for Chapter 7

Standards that apply alongside EU GMP

Pharma manufacturingcGMP (21 CFR 210 and 211): The FDA's equivalent for the US market, inspected at the same site on the same procedures when the product is sold there
Pharma manufacturingEU GMP Annex 11: The annex on computerised systems, read with Chapter 4 wherever a record the chapters ask for is kept electronically
Pharma manufacturingICH Q7: GMP for active substances, which Part II of Volume 4 carries for the starting materials the Part I products are made from
Pharma manufacturingICH Q10: The pharmaceutical quality system model Chapter 1 was rewritten around, so an inspector reads the chapter and the guideline together
Pharma manufacturingICH Q9: Quality risk management, which Part III of Volume 4 carries and Chapter 1 expects behind the decisions on how much control each step gets

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Guides and checklists for EU GMP

Toolkit

GxP toolkit

Guide

Complete guide to computerized system compliance

Guide

Integrating data integrity requirements into your QMS

Questions about EU GMP

What is Eudralex Volume 4?

Eudralex is the EU's collection of rules for medicinal products, and Volume 4 is its good manufacturing practice guidelines. Part I holds the requirements for medicinal products in nine chapters, Part II those for active substances, Part III related documents, Part IV the guidelines for advanced therapy medicinal products, and the annexes cover operations from sterile manufacture to computerised systems.

Is there an EU GMP certificate?

Yes. The competent authority of the member state issues it after an inspection with a satisfactory outcome, and enters it in the EudraGMDP database, where other authorities and customers can read it. No certification body is involved. The certificate is the regulator's, and it covers the site and the operations inspected.

What is the difference between EU GMP and cGMP?

Both ask a manufacturer for procedures, trained people, batch records and release testing, and a site selling into both markets can run one set of procedures. An FDA inspection with findings ends in a Form 483, an EU inspection in a GMP certificate or a statement of non-compliance, and the Qualified Person who certifies each batch has no FDA equivalent.

Does EU GMP apply to manufacturers outside the EU?

Yes, for any site whose product is imported into the EU. The importer has to verify the site works to EU GMP, and its Qualified Person has to re-test each batch in the EU unless a mutual recognition agreement lets the exporting country's inspection and testing stand in, as the agreement with the FDA does for most product types.

Can we add EU GMP to the standards we already run in Qualio?

Yes. Add it from the library and Qualio assesses the records you already hold against every chapter of Part I, beside 21 CFR 211 or ICH Q10 if you run those too. The procedures written for Part 211 count towards Eudralex without being re-filed, and the first assessment lists what is covered and what is new.

Which procedure will the inspector ask for first?

Bring it, with the rest of your procedures. We will show you Eudralex assessed against them chapter by chapter, with the gaps listed and the evidence exported the way the inspector asks.

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