Questions and Answers on Transport and Vehicle Qualification (Part 3)

During the ECA Live Online Training “Temperature-Sensitive Pharmaceuticals – Transport and Vehicle Qualification”, a number of interesting and practice-oriented questions were raised by the participants. These questions have been answered in writing after the event. To share some of the key insights with a broader audience, we have compiled a selection of these Q&As for general access.

Please find Part 3 (final part) below. Part 1 (Qualification of Vehicles and Passive Shipping Systems) and Part 2 (Temperature Mapping and Monitoring in Distribution) can be found in our news archive.

Part 3: Operational Control, Contingency and Periodic Review

3.1 – Are all packaging materials single-use? I assume that customers do not return thermal foils or similar materials, as this would mean sending back empty packaging. However, could cool blocks be returned for re-use since they are much smaller?
Not all. Many liners/foils are single-use (damage/cleanability concerns). Cool packs/PCM bricks can be re-used if you have procedures for inspection, cleaning, re-conditioning, segregation by life-cycle, and traceability; and if re-use was covered in qualification.

3.2 – For worst case road transportation, if a vehicle is crashed or broken, shall the shipper prepare a specific part in dispatch SOP dedicated to the allocation (depending on the fleet) of one or two trucks ready for replacement? Is it a common situation planned by big companies?
Yes. GDP requires contingency procedures to maintain temperature conditions and manage deviations. Companies should establish SOPs for emergency replacements (e.g., second truck availability, product transfer, or temporary storage). Large organisations commonly have such backup systems in place.

3.3 – What is a suggested timeframe for a periodic review?
There is no fixed regulatory interval. Typically, an annual review of calibration, maintenance, and performance trends should be performed. Requalification or remapping should follow any significant change.

3.4 – What is X-ray used for during transport/shipping?
Primarily for security screening (especially air cargo). It has no significant thermal impact. For most medicinal products, the radiation dose is negligible and poses no quality risk. For radiation-sensitive products, alternative screening methods or declarations should be implemented.

3.5 – For passive shipping systems, is the qualification duration always measured from the time of loading, or can the duration be extended if the system is temporarily stored at 2-8 °C (e.g. in a PSS 2-8 °C storage area)?
Duration starts at pack-out/closure. You may include qualified hold times at 2-8 °C (closed system, no reconditioning) if this scenario was explicitly tested and approved in OQ/PQ and defined in SOPs. Otherwise, assume no extension.