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.

Keywords

GLP Nonclinical laboratory studies Quality assurance unit Study director BIMO

Get full access to this article

View all access options for this article.

References

Food and Drug Administration, CDER 2003 Report to the Nation: Improving Public Health Through Human Drugs , Center for Drug Evaluation and Research, Rockville, MD; April 30, 2004:31.

Drug clinical trial inspection rose 24% last year. Dickinson's FDA Rev. 11, June 2004.

Food and Drug Administration, Nonclinical laboratories studies, proposed regulations for good laboratory practice, 41 Federal Register, 51,206–51,230 (November 10, 1976).

Food and Drug Administration, Bioresearch Monitoring Staff (HFC-30), Guidance for Industry, Good Laboratory Practices Questions and Answers. Rockville, MD: June 1981, revised December 1999 and September 2000:2–10.

Food and Drug Administration, Nonclinical laboratory studies good laboratory practice regulations, 43 Federal Register, 59,986–60,025 (December 22, 1978).

Food and Drug Administration, Bioresearch Monitoring Staff (HFC-30), GLP Regulations (Management Briefings) Post Conference Report. Rockville, MD: August 1979:5–12.

FDA Warning Letter. Rockville, MD: Center for Devices and Radiological Health, Office of Compliance; April 27, 2001.

Food and Drug Administration, Office of Regulatory Affairs, Compliance Program Guidance Manual, Program 7348.808, Good laboratory practice (nonclinical laboratories), Appendix A. Rockville, MD: February 21, 2001.

Food and Drug Administration, Office of Regulatory Affairs, Compliance Policy Guide, FDA access to results of quality assurance program audits and inspections (CPG 7151.02). Rockville, MD: Revised January 3, 1996:1–2.

10.

FDA Warning Letter, Reference no. CBER-00–026. Rockville, MD: July 3, 2000.

11.

FDA Warning Letter, Reference no. 01-HFD-45–0402. Rockville, MD: October 4, 2001.

12.

FDA Warning Letter, Reference no. 01-HFD-45–1101. Rockville, MD: November 29, 2001.

13.

FDA Warning Letter. Rockville, MD: Center for Veterinary Medicine, Division of Compliance: September 12, 2002.

14.

FDA Warning Letter. Rockville, MD: Center for Devices and Radiological Health, Office of Compliance; April 16, 2004.

15.

FDA Warning Letter. Rockville, MD: Center for Devices and Radiological Health, Office of Compliance; June 15, 2004.

16.

FDA Warning Letter. Rockville, MD: Center for Devices and Radiological Health, Office of Compliance; July 2, 2004.

17.

FDA Warning Letter. Rockville, MD: Center for Devices and Radiological Health, Office of Compliance; December 21, 2004.

18.

Food and Drug Administration, 21 CFR part 58 good laboratory practice regulations; final rule. 52 Federal Register, 33,768–33,782 (September 4, 1987).