Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
ICH Q7 provides guidance on the GMP requirements for manufacturing of APIs to assure that APIs meet the requirements for quality and purity. It is jointly enforced by FDA, EMA, and all ICH member health authorities.
All API manufacturers supplying to regulated markets globally. Covers the complete API manufacturing process from starting material through packaging.
- 01Impurity profiles for all APIs with limits justified by clinical and toxicological data
- 02Starting material specifications and control strategy
- 03In-process controls and specifications throughout the synthesis
- 04Cleaning validation for shared equipment with health-based exposure limits
- 05Laboratory controls including reference standards and reagent qualification
Original November 2000. Q&A documents issued 2003-2016. No formal revision — considered sufficiently mature. ICH Q3D (elemental impurities, 2014) supplements Q7 for inorganic impurity controls.
ICH Q7: frequently asked questions
Quick answers to common questions about ICH Q7.
What is ICH Q7?
ICH Q7 — Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients — is a guidance issued by the International Council for Harmonisation. ICH Q7 provides guidance on the GMP requirements for manufacturing of APIs to assure that APIs meet the requirements for quality and purity. It is jointly enforced by FDA, EMA, and all ICH member health authorities.
Who does ICH Q7 apply to?
All API manufacturers supplying to regulated markets globally. Covers the complete API manufacturing process from starting material through packaging.
What are the key requirements of ICH Q7?
ICH Q7 requires, among other things: Impurity profiles for all APIs with limits justified by clinical and toxicological data; Starting material specifications and control strategy; In-process controls and specifications throughout the synthesis; Cleaning validation for shared equipment with health-based exposure limits.
When was ICH Q7 last updated?
The current version of ICH Q7 dates from November 2000. Original November 2000. Q&A documents issued 2003-2016. No formal revision — considered sufficiently mature. ICH Q3D (elemental impurities, 2014) supplements Q7 for inorganic impurity controls.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
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When ICH Q7 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.