DANSK DSF/ISO/FDIS 21973 PDF

This document provides definitions, general requirements and points to consider for the transportation of cells for therapeutic use, which starts when the package is transferred from the sender to the transportation service provider and finishes when the package is received at its destination. This document is not intended for transportation of cells within a 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, nor a certain range of conditions such as ambient temperature control. NOTE – The transportation includes the storage during the transportation. NOTE – International, national or regional regulations or requirements can also apply to specific topics covered in this document.