Current good manufacturing practices for transfusion medicine.
Transfusion medicine is most tightly controlled in the US by CGMPs that are written as regulations, guidances, and quality management documents. Because the US regulatory scheme requires that each unit of human blood donated for transfusion (and other purposes) be documented from the moment of donor registration until the last component of that donation is finally disposed of, there is precious little that remains solely within the discretion of the treating physician who orders transfusions for her or his patients. An additional complication for transfusion medicine specialists is that the search for the requirements must extend to all possible areas of information, including the possibly unexpected source within the private sector.
Sazama
K
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Division of Laboratory Medicine, Medical College of Pennsylvania, Philadelphia, USA.
D001771:Blood Banks / Q000331:legislation & jurisprudence* / Q000592:standards*; D001782:Blood Donors; D001800:Blood Specimen Collection; D001803:Blood Transfusion; D006801:Humans; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration