标准编号:ISO 21973:2020
中文名称:生物技术 治疗用细胞运输的一般要求
英文名称:Biotechnology — General requirements for transportation of cells for therapeutic use
发布日期:2020-06
标准范围
This document specifies general requirements and reviews the points to consider for the transportation of cells for therapeutic use, including storage during transportation.
Transportation starts from the transfer of the packaged cells by the sender to the transportation
service provider and ends when the package is delivered to the receiver at its destination.
This document does not apply to transportation of cells 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.