Description of the Qualified Operation

The truck shall be used:

  • For transport of pharmaceuticals (in combination with medical devices)

  • To maintain and control air temperature at a set temperature.

  • In multi-temperature operation (< -20°C, +2°C to +8 °C or +15°C to +25°C) in two compartments.

  • At ambient temperature between -30°C and +40°C.

  • The vehicle will be used for transportation between temperature-controlled loading docks of storage locations.

  • According to the drivers instructions supplied by Thermo King on use of Thermo King equipment.

The objective of this qualification is to successfully qualify the designed use of this equipment.

The Operational Qualification conforms to the requirements of the Design Qualification: GDP-TK-DQ-SP-MT.

Parent topic: Operational Qualification