Cold chain: GDP compliance, EN 12830 and temperature traceability

Why temperature must be proven

For medicines as for many food products, it's not only the temperature that matters, but the documented proof that it was maintained throughout transport. Without reliable recording, you can't demonstrate a batch's compliance — and doubt often leads to its destruction.

Good Distribution Practice (GDP)

For medicines for human use, the European Good Distribution Practice (GDP) guidelines frame storage and transport. They require temperature conditions to be controlled, monitored and documented, to guarantee product integrity from manufacturer to point of dispensing.

The EN 12830 standard

On the instrument side, the European standard EN 12830 sets the requirements for temperature recorders used in the transport and storage of sensitive goods. A compliant recorder ensures readings are reliable, time-stamped and usable in the event of a check or dispute.

What it means operationally

• Suitable, calibrated sensors and recorders;
• Time-stamping and end-to-end traceability;
• A clear procedure for temperature deviations (alert, decision, documentation);
• Retention of records to answer inspections.

The role of dispatch

Cold compliance isn't limited to the truck: it integrates into the delivery's overall traceability. Linking temperature proof to order tracking and digital proof of delivery simplifies checks and secures the customer relationship.

Trace every delivery end to end. Try dropfleet free for 14 days — no credit card, ready in 5 minutes.