Title 21, Part 606 — Current Good Manufacturing Practice for Blood and Blood Components
17 sections
Section 606.3
Definitions.
Section 606.20
Personnel.
Section 606.40
Facilities.
Section 606.60
Equipment.
Section 606.65
Supplies and reagents.
Section 606.100
Standard operating procedures.
Section 606.110
Plateletpheresis, leukapheresis, and plasmapheresis.
Section 606.120
Labeling, general requirements.
Section 606.121
Container label.
Section 606.122
Circular of information.
Section 606.140
Laboratory controls.
Section 606.145
Control of bacterial contamination of platelets.
Section 606.151
Compatibility testing.
Section 606.160
Records.
Section 606.165
Distribution and receipt; procedures and records.
Section 606.170
Adverse reaction file.
Section 606.171
Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services.