2026-08-05
Navigating ICH Q7 & Chinese GMP: A Practical Checklist for Global Buyers
A buyer's guide to auditing pharmaceutical suppliers in China — what ICH Q7 and CNDA GMP certifications actually mean, and the red flags to watch for.
Why Compliance Matters More Than Ever
With regulatory bodies in the EU, US and Asia-Pacific tightening API import inspections, a supplier’s paper certifications are no longer sufficient. Buyers need practical, on-the-ground assurance that manufacturing practices match the documentation.
The Core Checklist
- ICH Q7 Scope Confirmation — Does the certificate cover the exact product you are buying, or just a broad facility certification?
- CNDA GMP Inspection History — Request the last two inspection reports; repeated “observations” in the same area are a risk signal.
- Data Integrity Controls — ALCOA+ implementation in analytical labs and production batch records.
- Change Control — A documented change control log reviewed at least annually; ask for one example change and trace its impact.
- Supply Chain Traceability — Ability to trace raw material lot numbers through to finished product, including toll processing.
Red Flags
- Supplier refuses to share redacted inspection reports.
- Certificates older than 24 months without a scheduled follow-up inspection.
- No dedicated QA headcount relative to production volume.
At Xi’an Greday Biological Technology, we share our current ICH Q7 certificate, CNDA GMP letter and latest third-party audit report with all qualified prospects on request.
Welcome to contact us to discuss API supply and contract manufacturing cooperation.