7.6 Good Laboratory Practices and Quality Assurance Unit

Revised 3/22/00

The University's Animal Resources Center (ARC) offers PIs and researchers the opportunity to conduct nonclinical laboratory studies in compliance with the Food and Drug Administration's Good Laboratory Practice regulations (GLPs). Compliance with GLPs is required for nonclinical safety studies that support or are intended to support applications for research or marketing permits for products regulated by the FDA. The regulations are listed in the Code of Federal Regulations, Title 21 CFR part 58 and define the minimal standards necessary for conducting a GLP study. The application of these regulations is intended to assure the quality and integrity of safety data. It is also important to note, that FDA GLPs do not pertain to studies utilizing human subjects, basic exploratory studies carried out to determine whether a test substance has any potential utility or studies carried out to determine physical or chemical characteristics.

The ARC recognizes the benefits of conducting GLP studies and in 1998 implemented a program to train personnel and incorporate standard operating procedures to assure GLP compliance. The University is one of only a select few Universities, in the west, with the capabilities to conduct GLP studies.

The ARC has on staff a full time Quality Assurance Manager who assists PIs and researchers with GLP compliance. Prior to initiating a GLP study at the ARC, please contact the Quality Assurance Manager to schedule a meeting, at (801) 585-1318. This meeting is to familiarize researchers and PIs with the requirements of the GLPs and how to prepare for a GLP study.