Glossary · ICH guidelines

ICH Q7 (GMP for active pharmaceutical ingredients)

Also known as: ICH Q7, Q7, API GMP, EU GMP Part II, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

ICH Q7 is the ICH guideline on good manufacturing practice for active pharmaceutical ingredients (APIs), adopted in 2000. It covers the manufacture of APIs from the point at which the API starting material enters the process and is implemented in the EU as Part II of EU GMP.

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In one sentence

ICH Q7 sets GMP for active pharmaceutical ingredients, from API starting material to release; in the EU it is Part II of EU GMP.

Example

An API manufacturer defines the API starting material in its synthesis route, applies ICH Q7 controls from that step onward, and documents batch production records, impurity profiles and the release of each API batch by its quality unit.

How it applies

Scope: APIs for human medicines made by chemical synthesis, extraction, cell culture or fermentation and recovery from natural sources. Requirements tighten as the process moves toward the final API steps.
Quality unit: An independent quality unit approves procedures, specifications and batch records and releases or rejects each API batch.
Content: Personnel, buildings and facilities, equipment, documentation and records, materials management, production and in-process controls, laboratory controls, validation, change control, complaints and recalls, and contract manufacturers.
Regional implementation: EU GMP Part II; FDA publishes ICH Q7 as guidance and applies it in inspections of API manufacturers. Q&A documents from ICH clarify its interpretation.
Technical documentation: The API section of the dossier (CTD module 3) relies on records kept under Q7, such as batch data, impurity profiles and validation reports. Keep them retrievable for the regulator and for customers' supplier audits.

ICH Q7 vs. EU GMP Part I

Part I of EU GMP governs the manufacture of finished medicinal products; Part II (ICH Q7) governs the manufacture of their active substances. A company that makes both applies each part to the corresponding step. Sterile finished products additionally fall under Annex 1, which does not apply to API manufacture as such.