Questions and Answers on Transport and Vehicle Qualification (Part 1)

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.

Part 1: Qualification of Vehicles and Passive Shipping Systems

1.1 – Do thermal covers count as passive shipping systems?
Yes, thermal covers are considered passive shipping systems. Passive systems are transport solutions that do not rely on an active energy source (such as electricity, dry ice, or mechanical refrigeration). Instead, they use insulating materials and sometimes phase change materials (PCMs) or cool packs to maintain temperature within a defined range for a certain period.

1.2 – If you are using Phase Change Material as the cooling unit and you expect the exposure to be above and below the corresponding temperature: How do you perform the preconditioning of the cooling packs - in the middle, or closer to the lower/higher end depending on the first exposure (above or below the limit)?
Always follow the manufacturer's instructions and the qualified pack-out configuration. If exposure is expected to start with high ambient temperature, the PCMs are typically conditioned slightly below their phase-change temperature to provide more cooling capacity. If exposure starts cold, they should be conditioned closer to the upper limit to avoid overcooling. Both warm-first and cold-first scenarios should ideally be verified during OQ and PQ.

1.3 – What are the minimum considerations when selecting the worst-case route(s) for the PQ on a passive container solution which will cover many distribution routes worldwide?
Key factors may include climatic conditions and seasonal variations, transport modes, durations and handover points, loading/unloading conditions, and performance history of logistics partners. Lane profiling and risk assessment are prerequisites for representative PQ route selection.

1.4 – How do URS and DQ apply to vehicle qualification for transporting medicinal products, considering critical requirements, acceptance criteria, and compliance documentation throughout the entire distribution process?
The User Requirement Specification (URS) defines the operational and regulatory needs (e.g., temperature range, loading capacity, air circulation, monitoring). The Design Qualification (DQ) confirms that the vehicle design and components meet these requirements. Subsequent IQ/OQ/PQ testing demonstrates that the vehicle performs as intended under defined conditions. Documentation should cover all critical requirements, acceptance criteria, and change control throughout the system lifecycle.

1.5 – Can we use trend data of an unqualified vehicle (large fleet) for qualification purposes?
Trend data from unqualified vehicles may support risk assessment and route characterization, but it cannot replace formal qualification. Annex 15 allows the use of external data only if its origin, integrity, and applicability are demonstrated and justified.

1.6 – Is it possible to just use OQ data (thermal chamber) to qualify a passive container solution and avoid real world PQs completely?
Not recommended. Chamber OQ characterizes capability, but PQ on real-world lanes (or well-justified simulated worst-case operational PQ) is needed to cover handling, loading, dwell times, and process variability.