FDA 21 CFR 606: cGMP for Blood and Blood Components * Free *

Date Published:
Thu, 04/01/2010

21 CFR 606 specifies current Good Manufacturing Practices for blood and blood products. 

Sections most commonly cited in software related deficiencies include:

  • 60 Equipment 
  • 100 Written Standard Operating Procedures
  • 140 Laboratory Controls
  • 160 Records