Title 21

PART 606

Part 606 - Current Good Manufacturing Practice For Blood And Blood Components

PART 606 - CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS 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.

21:7.0.1.1.3.1SUBPART A
Subpart A - General Provisions
21:7.0.1.1.3.1.1.1SECTION 606.3
   606.3 Definitions.
21:7.0.1.1.3.2SUBPART B
Subpart B - Organization and Personnel
21:7.0.1.1.3.2.1.1SECTION 606.20
   606.20 Personnel.
21:7.0.1.1.3.3SUBPART C
Subpart C - Plant and Facilities
21:7.0.1.1.3.3.1.1SECTION 606.40
   606.40 Facilities.
21:7.0.1.1.3.4SUBPART D
Subpart D - Equipment
21:7.0.1.1.3.4.1.1SECTION 606.60
   606.60 Equipment.
21:7.0.1.1.3.4.1.2SECTION 606.65
   606.65 Supplies and reagents.
21:7.0.1.1.3.5SUBPART E
Subpart E [Reserved]
21:7.0.1.1.3.6SUBPART F
Subpart F - Production and Process Controls
21:7.0.1.1.3.6.1.1SECTION 606.100
   606.100 Standard operating procedures.
21:7.0.1.1.3.6.1.2SECTION 606.110
   606.110 Plateletpheresis, leukapheresis, and plasmapheresis.
21:7.0.1.1.3.7SUBPART G
Subpart G - Additional Labeling Standards for Blood and Blood Components
21:7.0.1.1.3.7.1.1SECTION 606.120
   606.120 Labeling, general requirements.
21:7.0.1.1.3.7.1.2SECTION 606.121
   606.121 Container label.
21:7.0.1.1.3.7.1.3SECTION 606.122
   606.122 Circular of information.
21:7.0.1.1.3.8SUBPART H
Subpart H - Laboratory Controls
21:7.0.1.1.3.8.1.1SECTION 606.140
   606.140 Laboratory controls.
21:7.0.1.1.3.8.1.2SECTION 606.145
   606.145 Control of bacterial contamination of platelets.
21:7.0.1.1.3.8.1.3SECTION 606.151
   606.151 Compatibility testing.
21:7.0.1.1.3.9SUBPART I
Subpart I - Records and Reports
21:7.0.1.1.3.9.1.1SECTION 606.160
   606.160 Records.
21:7.0.1.1.3.9.1.2SECTION 606.165
   606.165 Distribution and receipt; procedures and records.
21:7.0.1.1.3.9.1.3SECTION 606.170
   606.170 Adverse reaction file.
21:7.0.1.1.3.9.1.4SECTION 606.171
   606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services.