ICH Q7: the global GMP guideline for APIs

What is ICH Q7?

ICH Q7 — Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients — is the harmonised guideline that defines GMP expectations for API manufacture. It is adopted across the EU, US, Japan and many other regions, and is the benchmark against which API sites are inspected.

Core principles

• Quality management — a documented system covering responsibilities, procedures and risk.
• Personnel — qualified, trained staff with defined responsibilities.
• Premises & equipment — designed to avoid contamination and cross-contamination.
• Documentation — specifications, batch records, SOPs, and full traceability.
• Production & in-process controls — validated processes, controlled changes, quarantined release.
• Validation — process and analytical method validation for critical steps.
• Change control, deviations, complaints, recalls — a functioning quality system, not just paperwork.

Where ICH Q7 applies

It applies from the receipt of starting materials through API production, but not to the pre-clinical or the finished-dose stages. API GMP is the foundation on which CEP, EDMF and DMF files stand.

How we work to Q7

Our quality system is built around ICH Q7, spanning R&D, synthesis, purification and QC release. We host customer and regulatory audits and support supplier qualification questionnaires end-to-end.

ICH Q7 is a guideline; national regulations add specifics. Confirm local GMP requirements with your authority.

Informazioni di carattere generale; non costituiscono consulenza legale o regolatoria. I requisiti cambiano — confermare sempre con l'autorità competente.