Purpose

This protocol defines the qualification of the equipment (a refrigerated unit designed and built by Thermo King with an ATP certified body) for the transportation, under temperature restrictions, of medicines.

The qualification is based on the following documents: GDP-TK-VMP, GDP-TK-DQ-TRA-ST, GDP-TK-IQ-TRA-ST and GDP-TK-OQ-TRA-ST.

The qualification is based on the following documents: GDP-TK-VMP, GDP-TK-DQ-TR-MT_A, GDP-TK-IQ-TR-MT_A and DP-TK-OQ-TR-MT_A.