QAU and Sponsor Monitoring

§58.25(a) of the FDA GLP Regulations states:

“a testing facility shall have a quality assurance unit (QAU) which shall be responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations in this part. For any given study, the quality assurance unit shall be entirely separate from and independent of the personnel engaged in the direction and conduct of that study…”

At UTMB, the independent QAU resides within the Regulatory Operations branch of the Institutional Office of Regulated Nonclinical Studies and remains separate from study conduct. The level of QAU involvement is dependent on each study and where it falls on the regulatory pathway.  For Animal Rule studies, QAU conducts in-life critical phase inspections as determined during study protocol development. For other studies, the level of QAU oversight is determined through interactions with the study sponsor and the Principal Investigator of the grant/contract. A Quality Agreement is typically negotiated, through ORNcS Regulatory Operations, for regulated studies when GLP is the reference standard for assuring data quality and integrity. This Agreement defines compliance expectations.

Sponsor monitoring visits are frequently a part of regulated studies and are hosted by QAU. The number and frequency of these visits is determined during grant/contract negotiations; therefore, involvement of ORNcS Leadership is required.