Included in this course are some current good manufacturing practices (cGMP) that might appear to only apply to donor centers/blood suppliers; however, there are federal regulations that apply to transfusion services. Transfusion service personnel who review cGMP sections of the Code of Federal Regulations (CFR) ensure their department provides quality and safe products and complies with the Food and Drug Administration's cGMP.
Additionally, reviewing the regulations provides insight into why specific policies and procedures are created by donor centers/blood suppliers. For example, the regulations explain the logic for some of the communications from the blood supplier concerning units involved in lookback or the labeling of autologous donor units. The time constraints placed on responding to inquiries from the donor center about the final disposition of units are based on regulatory requirements.
