Bioequivalence and Bioavailability Forum

Dear QA,

❝ RLD (from EMA) label claims "This medicinal product does not require any special storage conditions". Winter is going on in Europe and maximum temperature is below 20°C at both locations (shipper and consignee).

Not yet winter, please... Give us some more mild and sunny Autumn days !

❝ Can we ship RLD via DHL (without temperature controlled shipment) from supplier to sponsor by just keeping the datalogger during the transportation considering that temperature excursion above 40°C (accelerated stability condition) will not occur. RLD will be used in BE study. Same question for the shipment of IMPs from sponsor to CRO.

I would not find it shocking, if there are no specified storage conditions. In any case if the temperature is monitored by data loggers you will be able to quarantine the products when received, and if needed, to replace them in case of temperature excursion (what I would be worried about when winter really comes is freezing temperatures). Strictly no risk for the trial participants. Only risk for the sponsor: having to buy some reference product again, and loosing some time. Their problem.