Internal Pharmacy

• A designated pharmacy area with restricted access limited to authorised staff only.
• IMP management (receiving, repackaging, storing, randomisation, manufacture, batch release, sampling and testing, labelling, dispensing, blinding and emergency unblinding) that complies with both GMP and GCP.
• Designed storage area, with a quarantine area, IMP area, that meets the requirements for all storage conditions (room temperature, cold storage 2-8⁰C, light protection).
• Clean room area with laminar air flow cabinet dedicated for preparing formulation for parenteral use.
• Drug utilisation provided by a certified vendor according to internal procedures.
• Centralized, alarmed system for temperature and humidity monitoring and control (TESS system).

All presented processes are specified in Standard Operating Procedures, which are in accordance with the current legal status.