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.

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.

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