Layout of Sample-type Truck Qualification

The objective of this GDP qualification is to successfully qualify the designed configuration of the equipment mentioned in the Design Qualification: GDP-TK-DQ-SP-MT.

For this qualification three issues are important:

  • The flow of temperature-controlled air in the load space must reach all parts of the load space. Therefore, a fixed return air system is essential.

  • The capacity of the unit that is used to manage the temperature within the load space must be sufficient to maintain the products at the set temperature range recommended by the manufacturer of the product (pharmaceutical company). Therefore, the base colour white plus allowable 20% decal coverage is set to the DQ. Other darker colours would decrease the cooling capacity of the truck.

  • The temperature logging equipment used for the calibration process must be calibrated to each temperature range. This will be checked and confirmed during the OQ (Operational Qualification) process.

The equipment must comply with the three requirements as laid out above and should be measured with calibrated temperature dataloggers and must be registered as such. This will be checked and confirmed during the OQ (Operational Qualification) process.

Parent topic: Operational Qualification