A quality control unit is essential. In a large facility, there may be a department responsible for this function. In a small transfusion service, the quality control functions may be performed by a lead scientist or other qualified individual. There must be written procedures that define the responsibilities and operations of the quality control unit.
The responsibilities of the quality control unit, as specified in the Code of Federal Regulations, are:
- Approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products.
- Review production records to ensure that no errors have occurred or, if errors have occurred, that they have been fully investigated.
- Approve or reject drug products manufactured, processed, packed, or held under contract by another company.
- Approve or reject all procedures or specifications impacting the identity, strength, quality, and purity of the drug product.
Adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, in-process materials, and drug products must be available to the quality control unit.
All of the responsibilities and procedures applicable to the quality control unit should be in writing, and these procedures must be followed.
