Redundancy

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The page below is a sample from the LabCE course Current Good Manufacturing Practices for Transfusion Services. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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Redundancy

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; General

Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals

Part 600 Biological Products; General