This site is to educate CWRU researchers, like you, on the requirements of the FDA's Good Laboratory Practices (GLP) regulations in research studies using animals. These regulations apply to any animal studies for which results will be used to support applications for research or marketing permits for products regulated by the FDA. Such products include human and animal drugs or food additives, medical devices for human use, or biological products. GLP's apply to studies aimed at establishing the safety of drugs or devices, not to basic exploratory, mechanism of action, or efficacy studies.
GLP's are complex and require strict adherence for compliance with standards. Detailed standard operating procedures and record keeping are required for all aspects of the study. Since CWRU's Animal Resource Center does not, as a general practice, incorporate GLP into its standard animal care, most results obtained at this time in animal studies at this university cannot be described as GLP compliant and should not be so described in applications to the FDA.
At a minimum, GLP compliance requires the following:
- A study director, appointed by the institution, who acts as the single source of study control and assures that the protocol is approved and followed, that all experimental data are recorded, that GLP's are followed, and that all raw data, documentation, protocols, specimens, and final reports are archived as required.
- An independent Quality Assurance Unit that assures management that facilities, personnel, practices, and records are in compliance with regulations, maintains a master schedule sheet of studies, inspects each non-clinical study at intervals to assure compliance and reports findings to the Study Director and management, reviews the final report to assure that it accurately reflects the raw data, and prepares and signs a QA statement in the final report.
- Standard Operating Procedures for equipment use, maintenance, and calibration; for laboratory tests and methods; animal use issues such as identification, care, transfer, and necropsy; histopathology; handling test and control articles; data handling and storage. Any deviations from these SOPs must be authorized and recorded by the Study Director.
- A written protocol for each study that describes the objectives and methods for the conduct of the study.
- All data recorded in ink, dated, and initialed.
- Separate laboratory and animal facilities.
- Final report containing a compliance statement signed by the applicant, the sponsor, and the study director.
The following links will be helpful in further understanding these requirements and when they would be applicable to your research.
- FDA Guidance for Industry FAQs
- FDA GLP Regulations
- APLU Guide for Implementing a Safety Culture in Our Universities
If you have further questions and/or believe that GLP compliance may be required for your research, please contact:
Tami McCourt Steven
Compliance and Training Specialist
Phone: 216.368.3490 (School of Medicine Office of Research Administration)