FDA 21 CFR 606: cGMP for Blood and Blood Components
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21 CFR 606 specifies current Good Manufacturing Practices for blood and blood products.
Sections most commonly cited in software related deficiencies include:
- 60 Equipmentﾠ
- 100 Written Standard Operating Procedures (SOPs)
- 140 Laboratory Controls
- 160 & 165 Records and Reports
| Issuing Body | FDA Regulations |
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