Preclinical Studies Guidance for FDA GLP

Good Laboratory Practice (GLP) [21 CFR Part 58]

Good Laboratory Practice (GLP) deals with the organization, process and conditions under which laboratory studies are planned, performed, monitored, recorded and reported. These practices are intended to promote the quality and validity of Preclinical test data. Preclinical safety and toxicology studies should be performed under GLP conditions if they are intended to support applications for research or marketing permits to the FDA. All sections of the Code of Federal Regulations (CFR) are available online. Part 58 of Title 21 of the CFR is specific for the GLP regulations.

A properly designed and documented GLP study should make it possible to answer the following questions during the study for the researchers, after the study for FDA auditing, and also 10 years or more later:

• Who performed the study?
• How was the experiment carried out?
• Which procedures were used?
• Were there any problems?
• How were problems solved?

A list of frequently asked questions is available at the FDA web page for GLP Guidance Document. This provides answers to some of the basic queries surrounding GLP Preclinical studies.

Please provide notification 4-6 months in advance of a planned start date for any GLP studies at the University of Rochester. To incorporate quality systems elements (similar to what is found in a GLP-governed study) in a research plan, request a consultation with the Office of Regulatory Support through the Research Help Desk.