Current Edition Checked October 24, 2026
Adopted as FDA guidance and as Part II of the EU GMP guide.
What It Covers
GMP for the manufacture of active pharmaceutical ingredients, from the point at which starting materials enter the process to release of the API.
Who It Applies To
API manufacturers, and finished-dose manufacturers who must qualify and audit them.
Key Requirements
- A quality unit independent of production, with defined responsibilities.
- Process validation, cleaning validation, and change control appropriate to the stage of the process.
- Impurity profiles, stability, and retest dates for the API.
- Agents, brokers, traders, distributors, and relabelers held to the same traceability.
What an Auditor Asks to See
- Supplier qualification for API sources, including audits.
- Impurity profile and change notifications from the API maker.
Where Systems Fall Short
- API suppliers qualified on paper, never audited.
- Changes at the API maker not notified, or not assessed when they were.
How QES Helps
Supplier audits and quality agreements that make API changes visible before they reach the batch record.
Related Standards
Sources. ICH — Quality guidelines (opens in a new tab); European Commission — EudraLex Volume 4, EU GMP guidelines (opens in a new tab). Status checked October 24, 2026. This page summarizes ICH Q7; it does not reproduce or replace it. Buy the standard from its publisher, or read the regulation in its official text, before relying on a detail. Not legal advice.