🔔 Note: Stop playback at 1:34:04 to complete this lesson.
Presenter
Mark Seaton, PhD, DABT
Senior Pharmacokineticist
Division of New Drug Study Integrity (DNDSI)
Office of Study Integrity and Surveillance (OSIS)
Office of Translational Sciences (OTS)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Abstract
This presentation provides an introduction to the FDA’s Good Laboratory Practice (GLP) regulations, detailed in 21 CFR part 58, and the vital role of the Office of Study Integrity and Surveillance (OSIS) GLP team. GLP is a quality system designed to assure the quality and integrity of data from non-clinical safety studies, such as toxicology and safety pharmacology, which are essential for supporting investigational and marketing applications and ensuring the safety of human clinical trials. Historically, GLP regulations were established in 1977 under the Bioresearch Monitoring (BIMO) program due to findings of poor laboratory practices and fraudulent activities. The OSIS GLP team actively supports CDER’s review process by verifying data quality and integrity through surveillance and directed inspections. OSIS selects sites, prepares inspection assignments, participates in inspections, conducts compliance reviews, and provides crucial recommendations to review divisions. Inspection priorities include animal rule efficacy studies, “for-cause” investigations, and routine surveillance inspections (typically every two to five years). Inspections involve reviewing extensive documentation, facility tours, personnel interviews, and scrutinizing study, facility, equipment, and electronic data records. Findings are documented, leading to classifications of No Action Indicated (NAI), Voluntary Action Indicated (VAI), or Official Action Indicated (OAI). Ultimately, OSIS’s work ensures that all data supporting FDA regulatory decisions are reliable.