21 CFR § 606.3 - Definitions.
As used in this part:
(a) Blood means a product that is a fluid containing dissolved and suspended elements which was collected from the vascular system of a human.
(c) Blood component means a product containing a part of human blood separated by physical or mechanical means.
(d) Plasma for further manufacturing means that liquid portion of blood separated and used as material to prepare another product.
(f) Plateletpheresis means the procedure in which blood is removed from a donor, a platelet concentrate is separated, and the remaining formed elements are returned to the donor along with a portion of the residual plasma.
(g) Leukapheresis means the procedure in which blood is removed from the donor, a leukocyte concentrate is separated, and the remaining formed elements and residual plasma are returned to the donor.
(i) Processing means any procedure employed after collection, and before or after compatibility testing of blood, and includes the identification of a unit of donor blood, the preparation of components from such unit of donor blood, serological testing, labeling and associated recordkeeping.
(k) Distributed means:
(l) Control means having responsibility for maintaining the continued safety, purity, and potency of the product and for compliance with applicable product and establishment standards, and for compliance with current good manufacturing practices.
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