Abstract
Once a cell or tissue product has been manufactured, a controlled process must be in place for review and release before distribution of the product. The procedure and documentation surrounding product review and release is both a microcosm of the Quality Assurance/Quality Control (QA/QC) structure and an encapsulation of the scientific data generated during manufacturing. Review and release attest that the entire system from accession of product into the laboratory, through removal of final samples for testing, to labeling and transportation of the finished product, has functioned as intended. This chapter describes the processes involved in the review of production and testing records and for product release.
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Collins, N. (2009). Product Review, Release, and Administration. In: Gee, A. (eds) Cell Therapy. Springer, Boston, MA. https://doi.org/10.1007/b102110_18
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DOI: https://doi.org/10.1007/b102110_18
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