Temperature requirements should be confirmed by the product liable party
“Needing a cold chain” is not sufficient as a condition for complete commissioning. The transport requirements for different products may differ and the temperature range cannot be presumed by the name of “reagent” “pharmaceutical” or “biomedicine”. The application requirements and the basis should be provided by the manufacturer or product quality manager, and the programme should then be evaluated by the professional service provider.
This paper describes demand communication and quality management for the transport of commercial pharmaceutical products, and does not provide methods of handling the storage, packaging and transport of infectious or controlled biological materials; Such material shall be subject to special review by the relevant head of the institution.
It's suggested that four sets of information should be identified before the request for quotations.
| Infogroup | What do you need to know? | Who will provide the recommendations |
|---|---|---|
| Product requirements | Confirmed conditions and limitations of transport | Manufacturer or quality manager |
| Scope of services | What are the services involved in the delivery, transport, waiting and handover? | Service providers and clients |
| Evidentiary requirements | What authentication information, transport records and delivery documents are required | Quality and Procurement Team |
| Unusual duties | Who received the notification and who decided to follow up | Designated officials of both parties |
The IATA Temperature Transport Information and WHO-related guidance both place the controlled transport of goods in quality management systems. The option should be selected on the basis of whether it applies to the actual product and service scene, rather than comparing the nominal temperature only.
Packaging instructions and transport commitments to be viewed separately
The description of the performance of the packaging supplier is usually accompanied by applicable conditions. The expected voyage, FTP and packaging validation results are different information and cannot be substituted for one another. During the procurement evaluation, suppliers may be required to indicate the conditions for use of the information to be covered by the certification and whether there is a need for re-evaluation following a change in the programme.
For trans-shipment, customs clearance waiting and delivery connection, confirmation should be given as to whether the relevant services are included in the terms of reference. The use of a temperature-conservation package does not allow for the default provision of active temperature control services at every transport link.
How do we get the offer clearer?
The proposed quotations also indicate the boundaries of packaging services, monitoring services, transport services and destination services, and indicate the respective estimated timing of the information clearance, preparation and main transport. In respect of matters not yet identified, indicate the assumptions and those responsible for additional information.
If the product requirements, packaging configuration or destination change, the original offer and the original programme should be reconfirmed.
FAQ
The lower the temperature, the better the protection?
That's not the way to judge it. The requirements identified for the product should be met and “cooler” should not be considered “safer” on its own.
When an anomaly occurs during transport, it's bound to end?
The product quality person should be assessed on the basis of application. The logistics provider should provide a factual record and should not decide for itself whether or not the product is usable.
Can the same product be used directly for the same programme?
It should be compared with the requirements of the product and the conditions of service, confirmed by the responsible party and adopted, and should not be judged on the basis of a similar name alone.
Official Sources
- IATA: Introduction to the rules of the temperature-controlled transport
- WHO: Guidance on the quality of time and temperature-sensitive medical product storage and shipment
Date of information check: 2026-09-23. Specific product requirements and quality release are confirmed by the manufacturer or designated quality person.