Qualification is documenting that a piece of equipment does the job it is meant to do, and it comes down to three questions. WHO's technical supplement on pharmaceutical shipping containers (TRS 992, Annex 5, Supplement 13) defines the stages in this order, and none starts before the previous one is complete.
| Stage | Question | Evidence |
|---|---|---|
| IQ, installation | Was it installed correctly | Installation is documented against the specification and drawings |
| OQ, operation | Does it work correctly | Test under controlled conditions; all three repeats meet the acceptance criteria |
| PQ, performance | Does it work under real conditions | Field test with real shipments, three repeats |
For mobile equipment such as a shipping container the first stage is called design qualification (DQ); IQ is used for fixed installations, a cold room for example. If the supplier can provide a satisfactory DQ and OQ report, those two stages can be dispensed with. PQ cannot: WHO treats it as mandatory unless every shipment on every route is monitored, and asks for it to be run on the most demanding route for both summer and winter.
The protocol is written before testing. Transport duration, acceptable temperature range, payload, ambient temperature profile and logger location are the minimum headings of an OQ protocol; the result report is compared against those criteria. If the criteria are written after the results are seen, qualification loses its meaning.
Reusable containers can lose insulation through ageing and damage; WHO recommends periodic requalification, with the interval set by the user, typically annually or from a risk assessment.