The GMP Compliance Guide
by Vimal Veereshwarayya, PhD — Founder, Navira Quality Systems. Two decades in pharmaceutical quality (GCP, PV, clinical quality).
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, document control and Inspection Readiness — the Phase 1 GMP Core.
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 captured as work progresses.
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 is provided for general educational purposes only and is not regulatory, legal or compliance advice. It 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