EudraLex Volume 4 is the EU GMP guideline itself. It is published by the European Commission and given legal force through the Directives, which is why 'it is only a guideline' is a misreading.
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.
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Part I covers medicinal products in nine chapters. Part II covers active substances and aligns with ICH Q7. Part III holds supporting documents including ICH Q9 and Q10. The Annexes add activity- and product-specific requirements on top.
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The revised Annex 1 reorganised sterile manufacturing requirements around quality risk management and a documented contamination control strategy. Check the version in force and its transition dates on the Commission page before working to a downloaded copy.
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Covers the lifecycle from supplier assessment and validation through operation, audit trails, security, periodic evaluation and archiving. Read alongside PIC/S PI 041 for data governance expectations.
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Defines the validation master plan, the qualification sequence, the three process validation approaches, and brings transport verification and packaging validation explicitly into scope.
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Sets out the QP's personal, non-delegable responsibility, the documented basis for relying on other sites, and the treatment of unexpected deviations at certification.
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.