Quality Assurance

The UGA Quality Assurance Unit provides information and training for researchers about federal Good Laboratory Practices (GLP), the recognized rules governing the conduct of non-clinical safety studies that ensure the quality, integrity and reliability of the study data.

Good Laboratory Practices

The Good Laboratory Practice standards (GLPs) are federal regulations promulgated in the United States by both the Food and Drug Administration in 21 CFR Part 58 and the Environmental Protection Agency both for FIFRA in 40 CFR Part 160 and for TSCA in 40 CFR Part 792.

The Good Laboratory Practice regulations describe the minimal standards for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by FDA or EPA such as animal food additives, human and animal drugs, medical devices for human use, biological products, electronic products, or pesticide products.

The regulations do not pertain to studies utilizing human subjects or clinical studies for which the current Good Clinical Practice (cGCP) standards would apply. Nor do the GLPs pertain to basic exploratory studies carried out to determine whether a test article has any potential utility or, for FDA studies only, to determine physical or chemical characteristics of a test article.

UGA Limitations on GLP and GCP Supports

At this time, the University of Georgia does not provide in-house support for research activities governed by Good Clinical Practice (GCP) or Good Laboratory Practice (GLP) standards. The institution does not maintain the infrastructure, regulatory oversight, or quality systems required to conduct or sponsor studies that fall under these frameworks.

Researchers are advised that:

* GCP-regulated clinical trials, including those involving Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications, are not currently supported.

* GLP-compliant laboratory studies, particularly those intended for submission to regulatory agencies such as the FDA or EPA, are outside the scope of institutional capabilities.

While the university remains committed to promoting high standards of research integrity and ethical conduct, investigators pursuing GCP or GLP research are encouraged to collaborate with external institutions or contract research organizations (CROs) that are equipped to meet these regulatory requirements. When applicable, investigators are encouraged to consider the costs associated with obtaining these outside services when drafting their funding proposals.

UGA’s research portfolio is ever-changing, and we are currently developing a roadmap for future administrative services that would allow in-house support of these types of research activities.