Quality Assurance

Research Compliance

Marilyn M. Marshall, Quality Assurance Officer

The Quality Assurance Officer, within the Office of the Vice President for Research has been in place since June 2, 2003, and reports to the Director of Research Compliance, Alice Langen. One of the QA Officer's major responsibilities is to assure that all University of Arizona research conducted under GLP [Good Laboratory Practices] regulations fully comply with 21 CFR 58 [FDA] and 40 CFR 160 [EPA]:

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 [EPA] Good laboratory practices for conducting studies relating to health effects, environmental effects, and chemical fate testing.

• Review and sign GLP animal protocols before sending to IACUC, [University of Arizona/University Animal Care requirement]
• Maintain a master schedule of all non-clinical studies conducted at the testing facility
• Maintain copies of all protocols
• Inspect each study at intervals adequate to assure the integrity of the study, and maintain written and properly signed records of each inspection.
• Periodically submit to management, and the study director, written status reports on each study noting any problems and identifying or recommending appropriate corrective action.
• Determine that no deviations from approved protocols or SOPs were made without proper authorization and documentation.
• Review the final study report to assure that it accurately describes the methods and SOPs and that the reported results accurately reflect the raw data of the study.
  

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