Under WHO's 2015 technical supplement, a refrigerated road vehicle needs at least four tests: maximum and minimum load in the hottest season, then maximum and minimum load again in the coldest (Supplement 11, clause 2.3.4). After the first two tests the vehicle is only provisionally qualified; for year-round use the second pair must be finished too, and WHO notes this can take as long as six months.
For a passive container the calendar rests on repeats. Under Supplement 13, OQ and PQ are each run three times and every repeat must meet the acceptance criteria; the PQ (clause 2.4) needs at least three tests each for maximum and minimum payload, with the series repeated in the hottest and coldest part of the year. The example plan there counts at least 12 tests for one container type, two loading configurations and two temperature profiles, and each added variable grows the number. For a prequalified system the OQ report can come from the container supplier, but if the design or packaging changes, the OQ is redone.
Qualification is not done once and forgotten: for multi-use containers, clause 2.1.4 asks for requalification typically once a year, on risk assessment, or after a significant change in transport operations.
For medicinal distribution, clause 4.3.2 of the TİTCK GDP Guideline (İDD-KLVZ-02, Rev. 02) asks for equipment to be qualified before it is brought into use and after every significant change such as repair or maintenance, with the result approved by the responsible manager. The guideline is written for pharmaceutical wholesalers and does not apply to food transport by itself.
Put that calendar next to the cost sheet and the question of renting or buying a refrigerated vehicle gets answered from a different direction.
What follows from these texts: on a rented vehicle that arrives under a new plate each time, qualification costs as many times as it repeats over the contract, while on your own container it is one setup and an annual repeat. If your growth is short and irregular, accepting the repeated calendar and renting stays a sound call; once your shipment pattern has settled, building the file on equipment you own simplifies planning.


