Good Laboratory Practice
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. The Office of Regulatory Support (ORS) can help you incorporate quality systems elements similar to what is found in a GLP-governed study in your preclinical research plan.
Features
Our consultation will help you properly design and document your GLP study. With our help, you should be able to answer the following questions during the study, after the study for FDA auditing, and 10 or more years later:
- Who performed the study?
- How was the experiment carried out?
- Which procedures were used?
- Were there any problems?
- How were problems solved?
- What were the results?
Get Started
To get started, request a GLP consultation with the ORS.
Please provide notification four to six months in advance of a planned start date for any GLP studies at the University of Rochester. 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.
Resources
You can find more guidance on the FDA Preclinical Research web page and in the Code of Federal Regulations, Title 21, Part 58.
Joan E. Adamo, Ph.D., Director, Regulatory Support
Joan_Adamo@urmc.rochester.edu, (585) 275-0742
Carrie Dykes, Ph.D., Research Engagement Specialist
Carrie_Dykes@urmc.rochester.edu, (585) 275-0736
Shelby Johnson, Administrative Support
Shelby_Johnson2@urmc.rochester.edu, (585) 275-5327