Good Laboratory Practice (GLP) Regulations: Interpretation Techniques and Review of Selected Compliance Issues
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Good Laboratory Practice (GLP) Regulations: Interpretation Techniques and Review of Selected Compliance Issues Christine f. l e e Associate Scientist, AstraZeneca, Wilmington, Delaware
John Y. lee Executive Director, PharmaNetB, Inc., Farmingdale, New York; former FDA investigator, New Jersey District Office
Key Words GLP; Nonclinical laboratory studies; Quality assurance unit; Study director; BlMO Correspondence Address John Y. Lee, Executive Director, PharmaNetB, Inc.. 457 Main Street, #208, Fatmingdale, NY 11735-3510.
The Food and Drug Administration (FDA) good laboratory pradice (GLP) inspections in fiscal year 2003 increased signif;cantly at a level of 7l% over the previousyear.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 558.33) and the quality assurance unit
INTRODUCTION The Food and Drug Administration (FDA) conducted 728 domestic and international Bioresearch Monitoring (BIMO) inspections in fiscal year 2003. These inspections included 87 good laboratory practice (GLP) inspections, which represents a 170% increase in the number of GLP inspections compared to the 32 inspections conducted in fiscal year 2002 and a 71% increase compared to the average of 51 inspections conducted during the fiscal years 1997 to 2001. This represented the biggest increase among all types of inspection in the FDA's BlMO program. The next biggest increase was bioequivalence inspections, with a jump of 46% over fiscal year 2002. The FDA did not report any particular reason for the huge increase in GLP inspections, but several possible reasons might be the additional GLP studies needed to support the increase in the number of clinical trials, the types and complexity of products undergoing testing, and trials performed by foreign countries with limited experience and regulatory standards (1,2). This article reviews the background of the GLP regulations and the available FDA published references that should be used to interpret these regulations effectively,the FDA's GLP inspection program, and two areas (study direc-
(21 CFR 958.35). This article raiews 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 cowect and efective interpretations of the regulations, and the specific interpretations of the GLP requirements for the study director and quality assurance unit.
tor and quality assurance unit [QAU]) that have been the target of repeat citations in recent FDA warning letters issued for GLP inspections.
BACKGROUND O F G O O D L A B 0 R A T 0 RY P R A C T l C E REGULATIONS Prior to 1976,the FDA conducted inspections of nonclinical laboratory studies and study sites on a "for-cause"basis to ensure the quality of the nonclinical study data submitted to the FDA. The for-cause inspections were usually triggered when data submitted to the FDA contai
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