标准摘要
[中文适用范围]： 本文件规定了一般要求，并回顾了治疗用途细胞运输时要考虑的要点，包括运输过程中的储存。 运输从发送者将包装好的细胞转移到运输服务提供商开始，到包裹交付到目的地的接收者时结束。 本文件不适用于在一个设施内运输细胞。 该文件包括运输计划的制定，包括验证和确认、客户与运输服务提供商之间的沟通以及相关文件。 本文件未规定运输容器规格、环境温度控制等特殊运输条件。 [外文原描述]： 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.
英文名称Biotechnology — General requirements for transportation of cells for therapeutic use