The GMP Compliance Guide
A practical reference for pharmaceutical quality teams navigating GMP compliance — and the new AI-governance layer reshaping it.
The standards the guide cites
21 CFR Part 211
cGMP for finished pharmaceuticals (FDA).
EU GMP Annex 11
Computerised systems — operational IT controls.
EU GMP Annex 22 (Draft 2025)
AI/ML in GMP — treated as an internal-control reference.
FDA CSA Final Guidance (Feb 2026)
Risk-based computer software assurance.
MHRA Data Integrity
ALCOA+ expectations across the record lifecycle.
WHO TRS No. 996 Annex 5
Good data and record-management practices.
What's Inside
Four Sections
Written for working QA teams.
Regulatory Landscape
FDA, EU GMP, ICH, and PIC/S — and the new AI-governance layer (EU AI Act, Annex 22 Draft) reshaping it.
Quality System Essentials
Deviation, RCA, CAPA, findings, document control, and inspection readiness — the GMP Core workflows.
The AI Evidence Gap
Why legacy audit trails don’t capture model version, prompt hash, retrieved evidence, or the human decision — and what does.
Inspection Readiness
Preparing for FDA inspections and EU GMP audits with evidence generated continuously, not retroactively.
Download the full guide
The full guide is a free, gated download. Share your work email and the PDF downloads instantly — we’ll email you a copy too.
This guide describes the regulatory landscape and how Verixa’s architecture is designed to align with it. Verixa is in design-partner validation; compliance determinations remain customer-owned.
See GMP Core