Quality is not a department — it's a culture. Every batch undergoes 50+ checks before it reaches a patient.
World Health Organization
Both plants — oral solids, injectables, liquids
European Directorate for Quality of Medicines
Plant 2 — injectables, sterile products
Therapeutic Goods Administration
Both plants — all dosage forms
Agência Nacional de Vigilância Sanitária
Plant 1 — oral solids
Quality Management System
Organization-wide
Environmental Management System
Both manufacturing sites
Site Master File submitted
15 ANDA filings under review
Every raw material and packaging component tested against pharmacopoeial specifications before acceptance.
Real-time monitoring during manufacturing — weight variation, hardness, friability, fill volume, seal integrity.
50+ tests per batch including assay, dissolution, impurities, microbial limits, and stability.
ICH-compliant accelerated and long-term stability studies. Ongoing stability monitoring for commercial batches.
QA review of complete batch documentation. Authorized Person release per GMP requirements.
Pharmacovigilance, complaint handling, and annual product quality reviews (APQR).