Blood/Biotechnology Industry Specific Definitions

Blood 

Whole blood collected from a single donor and processed either for transfusion or further manufacturing. [From §606.3(a)]

Compatibility Testing 

The procedures performed to establish the matching of a donor's blood or blood components with that of a potential recipient.  [From §606.3(j)]

Component 

That part of a single-donor's blood separated by physical or mechanical means. [From §606.3(c)]

Control

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. [From §606.3(l)]

Distributed 

(1) The blood or blood components have left the control of the licensed manufacturer, unlicensed registered blood establishment, or transfusion service; or

(2) The licensed manufacturer has provided Source Plasma or any other blood component for use in the manufacture of a licensed biological product. [From §606.3(k)]

Facilities

Any area used for the collection, processing, compatibility testing, storage or distribution of blood and blood components. [From §606.3(h)]

Leukapheresis 

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. [From §606.3(g)]

Plasma for Further Manufacturing 

That liquid portion of blood separated and used as material to prepare another product. [From §606.3(d)]

Plasmapheresis 

The procedure in which blood is removed from the donor, the plasma is separated from the formed elements and at least the red blood cells are returned to the donor. [From §606.3(e)]

Plateletpheresis 

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. [From §606.3(f)]

Processing 

Any procedure employed after collection and before 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. [From §606.3(i)]

Unit

The volume of blood or one of its components in a suitable volume of anticoagulant obtained from a single collection of blood from one donor. [From §606.3(b)]