manual should be marked with the date and the reason for removal. Obsolete computer
software necessary to reconstruct or trace records must also be archived appropriately.
1-6. LABEL CONTROL AND LOT RELEASE
a. Label control procedures should include controls for the following functions:
developing label specifications, approving vendors, receiving and quarantining labels,
pending completion of acceptance checks, managing defective labels, controlling
storage and inventory practice, issuing labels, and reconciling any discrepancies
following unit labeling.
b. Process controls should be in place for each stage of the labeling process to
ensure that only suitable units are available for labeling, that the blood is maintained at
the appropriate temperature during the labeling process, and that the correct labels are
c. Before blood can be made available for distribution, the completely labeled unit
should be reviewed for accuracy, including a review of appropriate manufacturing
records. A second person must verify the records and labels are complete and correct.
d. If a unit is relabeled, it must be subjected to the same controls and review as
the initially labeled unit.
1-7. ERROR AND ACCIDENT REPORTS, ADVERSE EVENTS AND COMPLAINTS
a. cGMP regulations require an investigation (with documentation) if a specific
manufacturing error could adversely affect patient safety or the purity, potency, safety,
or effectiveness of blood or a component.
b. An error or variance document must be maintained.
c. Adverse patient and donor events must be documented.
d. Guidelines for identifying units implicated in posttransfusion disease should be
established. Documented cases of posttransfusion hepatitis, HIV infection, and other
viral diseases must be reported to the facility that collected the transfused unit(s).
e. QA unit should ensure that the root cause of an error rather than a symptom of
the error, has been identified so that appropriate corrective measures can be taken.
f. FDA required reports:
(1) Fatalities related to blood transfusion or donation, must be reported
promptly to CBER. A report should be made by telephone (301-594-1191) within one
working day and a written report should be submitted within 7 days.