Quality Assurance
|
The Quality Assurance department works with students, staff and faculty to ensure that all University of Arizona research conducted is compliant with federal regulations guiding Good Laboratory Practices (GLP) for non-clinical lab studies supporting applications related to U.S. Food & Drug Administration, medical devices for human use, environmental health, and drugs for human and animal consumption. |
Marilyn M. Marshall, Quality Assurance Officer
Government regulations state that the Quality Assurance Unit shall monitor "each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the GLP regulations". Most specifically with 21 CFR 58 [FDA], Good laboratory practices for conducting non-clinical laboratory studies that support applications for research or marketing permits for products regulated by the FDA, including food, and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products; 40 CFR 160 Good laboratory practices for conducting studies relating to health effects, environmental effects, and chemical fate testing; and 40 CFR 792[EPA] Protection of Laboratory Environment.
Important Quality Assurance Links
|
U of A Links
|
Important off-site Links
|