Good Laboratory Practices (GLP)

Good Laboratory Practices Compliance. All nonclinical laboratory studies intended to support applications for research or marketing permits for products regulated by the FDA shall be conducted in compliance with Good Laboratory Practices (GLP) as specified in 21 CFR Part 58. The testing facility shall designate a Study Director who shall have overall responsibility for the technical conduct of the study, interpretation, analysis, documentation, and reporting of results. The facility shall establish a Quality Assurance Unit (QAU) that is entirely separate from and independent of the study conduct. The QAU shall monitor each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with GLP regulations. The QAU shall maintain a master schedule sheet of all studies conducted at the facility, shall inspect each study at intervals adequate to ensure the integrity of the study, and shall report any problems likely to affect study integrity to the Study Director and management immediately. All raw data, documentation, protocols, final reports, and specimens shall be retained for the period required by 21 CFR 58.195.