Good Laboratory Practice (GLP) Regulations: Interpretation Techniques and Review of Selected Compliance Issues

Abstract

The Food and Drug Administration (FDA) good laboratory practice (GLP) inspections in fiscal year 2003 increased significantly at a level of 71% over the previous year. A review and analysis of recently issued FDA warning letters for nonclinical laboratory studies found that the two major GLP compliance deficiencies were study director responsibility and authority (21 CFR §58.33) and the quality assurance unit (21 CFR §58.35). This article reviews the background of the GLP regulations, the FDA GLP inspection program, the importance of interpreting the GLP regulations, the use of published FDA references to ensure the correct and effective interpretations of the regulations, and the specific interpretations of the GLP requirements for the study director and quality assurance unit.