Hubertus pharmacy holds:

• two GMP conform manufacturing rooms (18m² each) including laminar air flow bench;

  • personal- and material lock
  • clean room classification (class D or ISO 8)
  • air conditioning and permanent temperature and humidity monitoring
  • qualified equipment for the specific manufacturing activities
• separate labelling room for labelling activities of primarily packaged dosage forms
• emergency backup generator in case of a power cut

Hubertus pharmacy holds:

• 1,000 m² storage area for study drugs to be stored at room temperature (15°C – 25°C)
• 35 m² in cooling cells at 2°C - 8°C
• three deep freezers for frozen goods up to -50°C
• all storage areas under permanent temperature and humidity monitoring
• separate quarantine areas for all storage temperatures
• separate storage areas for reserve- and retention samples (also in accordance with the FDA requirements)
• separate storage area for returns of study medication from study sites (worldwide)
• restricted access to all storage rooms
• registration as known consignee = „bekannter Versender“ at the German Federal Office of Civil Aeronatics
• alerting system in case of temperature out of range for all storage areas
• alerting system in case of burglary and power failure