D7 CODING AND LABELING OF CELLULAR THERAPY PRODUCTS D7.1 ISBT 128 CODING AND LABELING D7.1.1 Cellular therapy products shall be identified according to the proper name of the product, including appropriate modifiers and attributes, as defined in ISBT 128 Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions. D7.1.2 If the Processing Facility has…
C9 CELLULAR THERAPY PRODUCT STORAGE C9.1 Apheresis Collection Facilities shall control storage areas to prevent mix-ups, deterioration, contamination, cross-contamination, and improper release or distribution of products. C9.2 Apheresis Collection Facilities shall establish policies for the duration and conditions of storage prior to distribution to a Processing Facility or Clinical Program. C10 CELLULAR THERAPY PRODUCT TRANSPORTATION…
CM9 CELLULAR THERAPY PRODUCT STORAGE CM9.1 Marrow Collection Facilities shall establish policies for the duration and conditions of storage prior to distribution to a Processing Facility or Clinical Program. CM10 CELLULAR THERAPY PRODUCT TRANSPORTATION AND SHIPPING CM10.1 Procedures for transportation and shipping of the cellular therapy product shall be designed to protect the integrity of…
B6.4 ADDITIONAL REQUIREMENTS FOR ALLOGENEIC DONORS B6.4.1 Allogeneic donors and allogeneic recipients shall be tested for ABO group and Rh type using two independently collected samples. Discrepancies shall be resolved and documented prior to issue of the cellular therapy product. B6.4.2 A red cell antibody screen shall be performed on allogeneic recipients. B6.4.3 Allogeneic donors…
CLINICAL PROGRAM STANDARDS: B1 GENERAL B1.1 The Clinical Program consists of an integrated medical team housed in geographically contiguous or proximate space with a Clinical Program Director(s) and common staff training, programs, protocols, and quality management systems. B1.1.1 Clinical Programs that include non-contiguous institutions shall demonstrate common protocols, procedures, quality management systems, and review of…