|
Section 640.1
|
General requirements |
|
Section 640.2
|
Suitability of donor |
|
Section 640.3
|
Collection of the blood |
|
Section 640.4
|
Testing the blood |
|
Section 640.5
|
Modifications of Whole Blood |
|
Section 640.6
|
Red Blood Cells |
|
Section 640.10
|
General requirements |
|
Section 640.11
|
Suitability of donor |
|
Section 640.12
|
Collection of the blood |
|
Section 640.13
|
Testing the blood |
|
Section 640.14
|
Segments for testing |
|
Section 640.15
|
Processing |
|
Section 640.16
|
Modifications for specific products |
|
Section 640.17
|
Platelets |
|
Section 640.20
|
Suitability of donors |
|
Section 640.21
|
Collection of source material |
|
Section 640.22
|
Testing the blood |
|
Section 640.23
|
Processing |
|
Section 640.24
|
General requirements |
|
Section 640.25
|
Emergency provisions |
|
Section 640.27
|
Plasma |
|
Section 640.30
|
Suitability of donors |
|
Section 640.31
|
Collection of source material |
|
Section 640.32
|
Testing the blood |
|
Section 640.33
|
Processing |
|
Section 640.34
|
Cryoprecipitated AHF |
|
Section 640.50
|
Suitability of donors |
|
Section 640.51
|
Collection of source material |
|
Section 640.52
|
Testing the blood |
|
Section 640.53
|
Processing |
|
Section 640.54
|
U |
|
Section 640.55
|
Quality control test for potency |
|
Section 640.56
|
Source Plasma |
|
Section 640.60
|
Informed consent |
|
Section 640.61
|
Medical supervision |
|
Section 640.62
|
Suitability of donor |
|
Section 640.63
|
Collection of blood for Source Plasma |
|
Section 640.64
|
Plasmapheresis |
|
Section 640.65
|
Immunization of donors |
|
Section 640.66
|
Laboratory tests |
|
Section 640.67
|
Processing |
|
Section 640.68
|
General requirements |
|
Section 640.69
|
Manufacturing responsibility |
|
Section 640.71
|
Records |
|
Section 640.72
|
Reporting of fatal donor reactions |
|
Section 640.73
|
Modification of Source Plasma |
|
Section 640.74
|
Products stored or shipped at unacceptable temperatures |
|
Section 640.76
|
Albumin (Human) |
|
Section 640.80
|
Processing |
|
Section 640.81
|
Tests on final product |
|
Section 640.82
|
General requirements |
|
Section 640.83
|
Labeling |
|
Section 640.84
|
Plasma Protein Fraction (Human) |
|
Section 640.90
|
Processing |
|
Section 640.91
|
Tests on final product |
|
Section 640.92
|
General requirements |
|
Section 640.93
|
Labeling |
|
Section 640.94
|
Immune Globulin (Human) |
|
Section 640.100
|
General requirements |
|
Section 640.101
|
Manufacture of Immune Globulin (Human) |
|
Section 640.102
|
The final product |
|
Section 640.103
|
Potency |
|
Section 640.104
|
Alternative procedures |
|
Section 640.120
|
Antibody to Hepatitis B Surface Antigen |