[Code of Federal Regulations] [Title 21, Volume 7] [Revised as of April 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR606.3] [Page 45-46] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 606_CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS--Table of Contents Subpart A_General Provisions Sec. 606.3 Definitions. Subpart A_General Provisions Sec. 606.3 Definitions. Subpart B_Organization and Personnel 606.20 Personnel. Subpart C_Plant and Facilities 606.40 Facilities. Subpart D_Equipment 606.60 Equipment. 606.65 Supplies and reagents. Subpart E [Reserved] Subpart F_Production and Process Controls 606.100 Standard operating procedures. 606.110 Plateletpheresis, leukapheresis, and plasmapheresis. Subpart G_Finished Product Control 606.120 Labeling, general requirements. 606.121 Container label. 606.122 Instruction circular. Subpart H_Laboratory Controls 606.140 Laboratory controls. 606.151 Compatibility testing. Subpart I_Records and Reports 606.160 Records. 606.165 Distribution and receipt; procedures and records. 606.170 Adverse reaction file. 606.171 Reporting of product deviations by licensed manufacturers, unlicenses registered blood establishments, and transfusion services. Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360j, 371, 374; 42 U.S.C. 216, 262, 263a, 264. Source: 40 FR 53532, Nov. 18, 1975, unless otherwise noted. As used in this part: [[Page 46]] (a) Blood means whole blood collected from a single donor and processed either for transfusion or further manufacturing. (b) Unit means 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. (c) Component means that part of a single-donor's 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. (e) Plasmapheresis means 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. (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. (h) Facilities means any area used for the collection, processing, compatibility testing, storage or distribution of blood and blood components. (i) Processing means 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. (j) Compatibility testing means the procedures performed to establish the matching of a donor's blood or blood components with that of a potential recipient. (k) Distributed means: (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. (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. [40 FR 53532, Nov. 18, 1975, as amended at 64 FR 45370, Aug. 19, 1999; 65 FR 66635, Nov. 7, 2000; 66 FR 1835, Jan. 10, 2001; 66 FR 40889, Aug. 6, 2001]