标准摘要
[中文适用范围]： 本文件规定了用于容纳治疗用途细胞的包装设计的一般要求和注意事项。 本文件适用于用于容纳治疗用途细胞最终产品及其起始材料和中间材料的包装。 本文件不适用于： a) 在制造过程中用于处理细胞的容器，例如细胞培养瓶或培养袋； b) 装有运输包裹的运输集装箱； c) 使用包的服务，例如存储服务。 注 1：附件 A 中给出了包装、包裹和运输容器的示例。 注 2：包装设计包括通过试制、测试和实施质量管理确保所设计的包装按照要求的规格制造的过程。 注 3：国际、国家或地区法规或要求也适用于本文件涵盖的特定主题。 [外文原描述]： This document specifies general requirements and considerations for the design of packaging used to contain cells for therapeutic use. This document is applicable to packaging intended to contain the final products of cells for therapeutic use, as well as their starting and intermediate materials. This document does not apply to: a) receptacles used for processing cells in manufacturing processes, e.g. cell culture flask or bag; b) shipping containers containing packages for transportation; c) services that utilize packages, e.g. storage services. NOTE 1 Examples of packaging, packages and shipping containers are illustrated in Annex A . NOTE 2 The design of packaging includes processes to ensure that the designed packaging is manufactured to a required specification through trial manufacturing, testing and implementation of quality management. NOTE 3 International, national or regional regulations or requirements can also apply to specific topics covered in this document.
英文名称Biotechnology — Bioprocessing — General requirements for the design of packaging to contain cells for therapeutic use