API

Active Pharmaceutical Ingredients are the biologically active substances in finished drug products. API manufacture is regulated under ICH Q7 (Good Manufacturing Practice for Active Pharmaceutical Ingredients), adopted by FDA, EMA, MHRA, PMDA and the rest of the ICH region.

APIs require full batch records, identity testing at every step, change control, deviation handling, qualified-person release into the finished-drug supply chain, and contamination control aligned with the API's toxicological profile (see OEL / OEB).

V5's pharma profile is API-aware: kiosk dispense enforces identity test before use, weighing tolerances are tightened automatically for potent / high-OEB APIs, and the batch record captures every charge with operator + reviewer e-signatures.