Abstract
A system is required for the unique identification (accessioning), tracing, and tracking of cells entering the current Good Manufacturing Practices (cGMP) facility for manufacturing from cell collection through to release, distribution (or disposal), and administration of the final product. The difference between tracing and tracking relates to the direction in which a process is followed. Tracing follows the process from the current point in time to where it began. Tracking follows the emerging path forward from the starting point to wherever the process currently is. This chapter discusses the general requirements and gives specific examples of how the procedure is handled at one facility.
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References
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Acknowledgments
This work was supported in part by a Core grant (RP180785) from the Cancer Research and Prevention Institute of Texas.
I should like to thank Sara Richman of the Center for Cell and Gene Therapy for reviewing this chapter.
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Bloom, J., Gee, A.P. (2022). Product Accessioning, Tracing, and Tracking. In: Gee, A.P. (eds) Cell Therapy. Springer, Cham. https://doi.org/10.1007/978-3-030-75537-9_29
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DOI: https://doi.org/10.1007/978-3-030-75537-9_29
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