Part 210 of the Code of Federal Regulations (CFR) Title 21 applies to all drug manufacturing, including blood and blood components. Some regulations that are included in Part 211 also apply to blood. There are more specific regulations for blood and blood components in Part 600. Because these sections were created at different times, there is noticeable redundancy.
Not all activities in the transfusion service are regulated by the cGMP sections of the CFR. For example, billing and transport of specimens are not part of the cGMP regulations. Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; GeneralPart 211 Current Good Manufacturing Practice for Finished PharmaceuticalsPart 600 Biological Products; General