Operational Qualification Checklist

For each individual equipment (vehicle + refrigerated unit) a specific TK PharmaSolutions - IQOQ Check-MUL document has to be completed by the Thermo King official dealer. The latest valid revision of this document has to be used and is available from Thermo King EMEA InfoCentral intranet.
This document confirms that:

  • Installation is conducted as per GDP-TK-IQ-VP-MT.

    Installation is conducted as per GDP-TK-IQ-TRA-ST.

    Installation is conducted as per GDP-TK-DQ-TR-MT_A.

    Installation is conducted as per GDP-TK-DQ-TR-MT.

    Installation is conducted as per GDP-TK-IQ-VPU-ST.

  • A calibration check has been performed in an empty body for each qualified range. This calibration check is performed for the controlling sensors and the datalogger sensors and the results are attached to this document. The results are available on request in electronic format.

    A 3-temperature calibration check has been performed and the results attached to this document. The results are also available on request in electronic format.

  • All required risk management and due diligence protocols are in place and comply with the GDP requirements. This protocol's minimum requirements should be:

    • Scheduled Maintenance

    • Breakdown repairs

    • Annual 3-temperatures calibration check

    • Availability of Service History

    • Asset Management

Parent topic: Operational Qualification