EU GMP is the European regulatory framework for pharmaceutical manufacturing quality , Annex 11 specifically governs computerised systems.
Definition
EU GMP is the set of Good Manufacturing Practice guidelines published under EudraLex Volume 4 that apply to medicinal products manufactured within or imported into the European Union. It covers site quality systems, personnel, premises, equipment, documentation, production, quality control, and computerised systems. Compliance is enforced by national medicines agencies and the EMA, with findings published in the EudraGMDP database.
What this means when you're hiring
Any engineer or manager working in a European pharma or biotech facility needs to understand EU GMP , not just the headline principles, but the specific annexes relevant to their system. Annex 11 for computerised systems, Annex 15 for qualification and validation, Annex 1 for sterile manufacturing. I use knowledge of relevant annexes as a proxy for real regulated manufacturing experience.
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