The manufacturing block is an independent cGMP facility dedicated only for manufacturing of BCG Vaccine. The block consists of ground plus two floors, in which the upstream process is done in the first floor and downstream process in the ground floor. The upstream facility has dedicated glassware washing and garment washing in first floor back side. The upstream consists of Media preparation, Culture propagation, Harvesting and preparation of Final bulk.
The production facility is well equipped with all essential machines & equipments. The manufacturing process is under taken as per the Master formula record following the required protocols and SOP’s. All the critical activity are undertaken in Grade A Classification. Necessary clean room procedure and gowning procedure are being followed.
Regulatory requirements as per Schedule M and CGMP norms are adhered in all stages of production. Production activities are undertaken by qualified and experienced staff. Each and every stage of production is monitored and recorded.