Abstract / scope
This document specifies general requirements and reviews the points to consider for the transportation of cellular therapeutic products, including storage during transportation. Transportation starts from the transfer of the packaged cellular therapeutic products by the sender to the transportation service provider and ends when the package is delivered to the receiver at its destination.
This document is applicable to cellular starting materials (including those for tissue engineered products) and intermediates of cellular therapeutic products.
This document does not apply to transportation of cellular therapeutic products within one facility.
This document includes the development of a transportation plan including verification and validation, communication between the client and the transportation service provider, and associated documentation.
This document does not specify particular conditions for transportation such as specification for shipping container, ambient temperature control, etc.