ICH Q7

ICH Q7 sets the GMP expectations for the manufacture of APIs intended for use in human drugs. Adopted as FDA industry guidance and as Part II of EU GMP. Covers quality management, personnel, buildings & facilities, equipment, documentation & records, materials management, production, process controls, packaging & labelling, storage & distribution, laboratory controls, validation, change control, complaints & recalls, contract manufacturers, agents/brokers, APIs by cell-culture/fermentation, APIs for clinical trials.

V5's API-mode pharma profile maps directly to Q7 sections 5 (production), 6 (documentation), 8 (process controls), 12 (validation) and 13 (change control).