CASE STUDY 3: Critical Review of Quality and Manufacturing Data | Emer-Pen is part of General-Pharma’s auto-injector portfolio. It is a single-use drug-device combination product, comprising device components with sterile injectable solution cartridge. Emer-Pen is used in life-threatening emergencies prior to gaining access to qualified medical care. Approximately 4 million packs (2 devices per pack) were prescribed in the local market during financial year 2015-16.
Global Head Sterility Assurance, Cell and Gene Technologies,