Free reference

The Dual-Market Gap Map

FDA GMP and EU GMP, side by side across 24 quality-system dimensions — with the structural delta between them and the one control that satisfies both regulators, so you build once, to the highest common bar.

What’s inside

·24 dimensions, 8 groups — governance, people & release, facilities, validation & data integrity, specifications, lifecycle, supply chain, and oversight
·The FDA rule and the EU rule for each dimension, with primary citations (21 CFR 211, EudraLex Volume 4, the annexes, and the shared ICH guidelines)
·The delta that matters — the ~20% where the systems diverge is called out in teal; the ~80% already aligned is muted, so the consequential differences carry the eye
·The Qualified Person, Annex 1, GDP, validation vocabulary, supplier agreements — the structural deltas that break export programs, each with the highest-bar move
·A build-to-the-highest-bar action for every row — the single control that meets both regulators at once

It’s the companion reference to the deep dive, “EU GMP vs. FDA GMP: A Deep Dive for Export-Ready Manufacturers” — where each delta is worked out clause by clause.

2-page PDF. By Intrepid Scientific. Free. A triage reference, not a legal compliance determination.

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