How can we ensure temperature compliance during transport of medicines requiring cold chain transport?

Ensuring compliant transport temperatures for cold-chain medicines requires a systematic approach to validation and monitoring. First, you need to conduct “transport validation”. This means demonstrating that your chosen transport route, packaging solution (such as insulated boxes and ice packs) and transport equipment can keep the medicines within the specified temperature range, usually 2–8°C, even under worst-case conditions, such as the hottest summer weather and the longest transport time. This is usually done by placing multiple temperature loggers inside the transport containers and conducting actual or simulated transport. Second, a calibrated, independent temperature logger must be used to monitor the goods’ temperature throughout every actual shipment. On receipt, the recipient must check the temperature records immediately and may accept the goods only after confirming that the temperature remained within range throughout. Any temperature excursion must be investigated as a deviation.