Temperature excursions in transit: what buyers should do

A data logger alarm on arrival is one of the most stressful moments in medicine supply. A product is needed for patients, the shipment is finally at the door, and the temperature record suggests something went wrong. What the receiver does in the next few hours decides whether the stock can be assessed fairly, whether a claim succeeds, and whether the same problem returns on the next shipment.

This guide sets out a practical sequence for buyers, based on WHO and EU good distribution practice. It does not replace the receiver's own procedures or the manufacturer's instructions, and it gives no advice on clinical use.

What counts as an excursion

WHO defines a temperature excursion as an event in which a product is exposed to temperatures outside the ranges prescribed for storage or transport. Those ranges are set by the manufacturer from stability data and may differ between storage and transport. Three points follow:

• Cold counts as much as heat. Many refrigerated products are damaged by freezing, so a dip below 0°C on a 2 to 8°C shipment matters.
• An alarm is not a verdict. Logger alarm limits are programmed in advance, by the device maker or the shipper, and may be tighter than the product's allowance. WHO's model guidance says stability data must demonstrate the acceptable excursion time during transport, which is what the assessment uses.
• No data is a problem in itself. A logger that failed or was not started cannot show that the range was held.

Prepare before the shipment arrives

Many excursion disputes are settled by what was agreed before dispatch. Before a cold-chain shipment leaves India, a buyer can:

• agree in the quality agreement who assesses an excursion, how quickly, and what data they need
• obtain the product's storage and transport ranges from the product information, and ask whether the manufacturer will share its excursion allowance
• confirm the logger model, serial number and alarm limits, and how to stop and download it, since WHO notes that some devices need extra software or a docking station that the receiver may not have
• name the person who will receive the goods, and make sure correct storage is available at the expected arrival time, including weekends
• check the insurer's notification rules and the carrier's claim process
• keep a short receipt checklist ready at the delivery point

The receiver should also keep monitoring records for as long as national rules require. WHO's good storage and distribution practices expect these records to be available to regulators on inspection.

The first hours: steps on receipt

1. Note it on the delivery receipt. Under the Montreal Convention 1999, accepting cargo without complaint is prima facie evidence that it arrived in good condition. Write the alarm or visible damage on the receipt before signing.
2. Move the goods into correct storage under quarantine. Keep the product at its labelled condition, clearly marked and kept apart from usable stock. WHO's good storage and distribution practices (TRS 1025, Annex 7) call for suspect containers, or the whole delivery if needed, to be quarantined for investigation, and the EU guidelines require products awaiting a decision to be segregated.
3. Stop and download the logger. Save the raw file and the summary report, and record the logger serial number.
4. Record the condition of the shipper. Photograph the outer box, labels, seals and any indicators. Note the state of the coolant, such as whether gel packs were still frozen or dry ice remained.
5. Keep everything. Hold the packaging, coolant and logger until the supplier and insurer confirm they no longer need them.
6. Notify in writing. Tell the supplier and the carrier the same day where possible, with the logger file, photographs, air waybill number, batch numbers and arrival time.
7. Wait for a documented decision. Do not use, return or destroy the stock until the disposition is agreed in writing.

Who decides whether stock can be used

WHO guidance says written procedures should exist for investigating temperature deviations. If the transporter notices a deviation, it should report it to the supplier, distributor and recipient, and if the recipient notices it, it should report to the distributor. The EU guidelines similarly require excursions in transport to be reported to the distributor and the recipient of the affected products.

The assessment itself compares the recorded temperatures and durations with the manufacturer's stability data. It is normally carried out by the manufacturer or marketing authorisation holder, or by the supplier's quality team using information from the manufacturer. The receiver's responsible person then accepts or rejects the conclusion under local rules. For returned refrigerated products, the EU guidelines allow a return to saleable stock only with documented evidence that conditions were maintained, or a risk assessment showing that product integrity is intact.

If a product from an affected shipment has already been dispensed, the supplier and the manufacturer should be told at once so they can decide whether a pharmacovigilance or quality report is needed. What a pharmacovigilance report needs explains the reporting side.

Claims, insurance and time limits

Time limits are short. Where the Montreal Convention applies, a complaint about damage to cargo must be made in writing promptly after discovery and at the latest within 14 days of receipt. A complaint about delay must be made within 21 days of the goods being placed at the consignee's disposal. Without a timely complaint, no action lies against the carrier except in cases of fraud.

Insurance follows its own rules. Under CIP the seller arranges all-risk cover, but standard cargo clauses list exclusions such as delay and inherent vice, so temperature cover should be confirmed before shipment, not after. Incoterms for pharmaceutical exports explains where risk sits under each rule. Insurers usually want the logger file, photographs and the supplier's assessment, and may appoint a surveyor before goods are destroyed.

If the stock is rejected, it stays in quarantine until return or destruction is agreed. WHO guidance asks that rejected and returned products be securely packaged, clearly labelled and sent with supporting documents. Destruction follows the destination's rules for pharmaceutical waste, and the receiver should keep the destruction record, because both the supplier and the insurer will ask for it.

Finding the cause and preventing a repeat

Most excursions trace back to a few causes:

• Packaging that did not match the lane. The validated duration or the ambient profile did not cover the real route, for example a summer profile through a Gulf hub.
• Clearance holds. Goods waited at export or import clearance because a permit or document was missing.
• Missed connections. A transit hub held the shipment longer than planned.
• Packing errors. Frozen packs touched a refrigerated product, coolant was not conditioned correctly, or the logger was placed outside the qualified position. WHO's packing rules address each of these.

A useful investigation report names the cause, the evidence and the corrective action, such as re-qualified packaging, a different routing, cool-room booking at the arrival airport, or a rule that goods are not packed until the import permit is in hand. The cold-chain transit checker helps test a lane before the next dispatch, and Cold-chain shipping of biologics from India covers packaging and lane planning in more detail.