Abstract
Compliance with current good tissue practices (cGTP) and current good manufacturing practices (cGMP) regulations is central to the efficient manufacturing of cell therapy products and vectors. The oversight of these activities falls to the quality assurance group who must devise and maintain an efficient quality program which tracks all aspects of facility operations to ensure that products are prepared under conditions that ensure their safety, purity, and potency. This chapter describes the development and maintenance of such a quality program (QP) (Food and Drug Administration. Guide to inspections of quality systems. https://www.fda.gov/files/Guide-to-Inspections-of-Quality-Systems.pdf. Last accessed 13 July 2020, 1999).
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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 would like to thank Sara Richman of the Center for Cell and Gene Therapy for reviewing this chapter.
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Gee, A.P. (2022). Development and Maintenance of a Quality Program. In: Gee, A.P. (eds) Cell Therapy. Springer, Cham. https://doi.org/10.1007/978-3-030-75537-9_11
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