Service
Pharmaceutical and life sciences transport (GDP)
Distribution of medicinal products and medical devices under Good Distribution Practice, with qualified vehicles, documented thermal mapping and formal handling of any excursion.
What GDP requires of a carrier
Good Distribution Practice (GDP, European Commission guidelines 2013/C 343/01) requires that a medicinal product stays within the manufacturer’s stated storage conditions for the whole journey, and that this can be evidenced with records. For a haulier, that comes down to four concrete obligations:
- Use equipment that is qualified for the declared temperature range, not merely equipment that cools.
- Log temperature continuously and keep the records available to the marketing authorisation holder.
- Treat any temperature excursion as a deviation: report it, document it and investigate the cause.
- Train the personnel who handle the product, and keep that training on record.
Storage ranges covered
- +2 °C to +8 °C
- Pharmaceutical cold chain: vaccines, biologics, insulins and refrigerated product generally.
- +15 °C to +25 °C
- Controlled room temperature, the most common range for non-refrigerated medicines and the one most often neglected in summer.
- Below 0 °C
- Frozen product, per the manufacturer’s data sheet.
How a vehicle is qualified
Qualification means demonstrating, with data, that a specific trailer holds the declared range throughout its load volume — not just next to the probe.
- Thermal mapping of the box with multiple data loggers, to locate the worst-case points in both cooling and heating.
- Probe verification against a reference, so that the logged reading is reliable rather than indicative.
- Continuous logging from two independent probes for the whole job.
- Written procedures for loading, pre-cooling, incidents and delivery, inside the ISO 9001:2015 quality system.
What happens on a temperature excursion
It is reported before delivery, not after. The excursion appears on the graph with its start time, duration and peak value, is passed to the customer so their quality function can make a disposition decision on the product, and the cause is investigated within the quality system. The decision on whether the medicine remains fit for use always rests with the marketing authorisation holder, never with the carrier.
Frequently asked questions
Is CoolCargo a pharmaceutical wholesaler?
No. CoolCargo is the carrier: it provides transport under GDP guidelines to wholesalers, manufacturers and distributors who hold that authorisation. It neither stores nor distributes medicinal product on its own account.
Can CoolCargo be audited as a supplier?
Yes, and it is routine: pharmaceutical customers audit their carriers as part of the supplier qualification GDP requires of them. Quality system documentation, certificates and mapping records are available for audit on request.
Is heat-sensitive product carried alongside food?
On a full load the unit is dedicated, so the situation does not arise: one trip, one customer, one commodity. It is one of the reasons pharmaceutical freight moves FTL rather than consolidated.
Need to move temperature-controlled freight?
Tell us origin, destination, set point and volume. A dedicated account manager comes back with a firm quote within one working day. If it is urgent, call.