Ashford Paul, Distler Pat, Gee Adrian, Lankester Alan, Larsson Stella, Feller Irene, Loper Kathy, Pamphilon Derwood, Poston Leigh, Rabe Fran, Slaper-Cortenbach Ineke, Szczepiorkowski Zbigniew, Warkentin Phyllis
J Clin Apher. 2007;22(5):258-64. doi: 10.1002/jca.20146.
The publication of new standards for terminology and labeling marks an important step in ensuring consistency and traceability of cellular therapies at the global level. However, it is only with the widespread implementation of the standard that the benefits can be truly realized. This paper provides guidance on the practical aspects of adopting these new standards for organizations with differing current levels of computerization. It discusses project management, equipment, licensing, and validation topics.
术语和标签新标准的发布标志着在全球层面确保细胞疗法的一致性和可追溯性方面迈出了重要一步。然而,只有在该标准得到广泛实施时,其益处才能真正实现。本文为当前计算机化水平不同的组织采用这些新标准的实际操作提供指导。它讨论了项目管理、设备、许可和验证等主题。