Theradis Pharma has state-of-the-art facilities to meet all regulatory requirements (GMP, GDP and GCP) for the storage of Investigational Medicinal Products, material, documents and biological samples.
Theradis Pharma has two purpose-built premises:
Building 1
Dedicated to manufacturing, with a storage potential of 2000 m3 at ambient temperature (+15/+25°C), 3 cold rooms providing storage between + 2°C and +8°C, and freezer units for storage at -30°C and -80°C.
Dedicated to manufacturing, with a storage potential of 2000 m3 at ambient temperature (+15/+25°C), 3 cold rooms providing storage between + 2°C and +8°C, and freezer units for storage at -30°C and -80°C.
Building 2
Dedicated to Biobanking including storage units at ambient temperature (+15/+25°C), between +2°C and +8°C and freezer units for storage at -30°C and -80°C
Dedicated to Biobanking including storage units at ambient temperature (+15/+25°C), between +2°C and +8°C and freezer units for storage at -30°C and -80°C
The high-tech equipment meets the highest regulatory requirements: the qualification of the climatic chambers is carried out according to standard FD X15 140 and the validation of IT computerised systems is in accordance with Annex 11 of the GMP.
Access to these areas is secured and controlled by a personalised badge system.
The two buildings are protected by a security system which detects any discrepancies such as intrusion attempts, fire, power outage, and temperature or humidity variations outside the zone defined thresholds (24/7). This system is linked to a surveillance company for immediate intervention.
Back-up generators, one per building, supply electricity to each of the sites in the event of a power failure.