Which two federal agencies require compliance with Good Laboratory Practice Regulations?

Which two federal agencies require compliance with Good Laboratory Practice Regulations?

• A. Food and Drug Administration & United States Department of Agriculture
• B. National Institutes of Health & National Science Foundation
• C. National Science Foundation & Food and Drug Administration
• D. Environmental Protection Agency & Food and Drug Administration

Answer: (D)

GLP ensures the quality and integrity of nonclinical safety studies that regulatory agencies rely on to evaluate products. The two agencies that require GLP compliance are the Environmental Protection Agency and the Food and Drug Administration. The EPA uses GLP for nonclinical studies submitted to support registrations and other regulatory actions, ensuring studies are planned, conducted, and documented under standardized, auditable procedures with independent QA oversight. The FDA requires GLP for preclinical safety testing that supports the approval of drugs, biologics, and certain devices, with strict rules on how studies are designed, performed, recorded, and reported. This shared emphasis on consistent, reliable data helps regulators make informed decisions about safety and efficacy. Other agencies focus on research funding or welfare standards rather than GLP requirements for regulatory submissions, which is why the combination of EPA and FDA is the correct pairing.

GLP ensures the quality and integrity of nonclinical safety studies that regulatory agencies rely on to evaluate products. The two agencies that require GLP compliance are the Environmental Protection Agency and the Food and Drug Administration. The EPA uses GLP for nonclinical studies submitted to support registrations and other regulatory actions, ensuring studies are planned, conducted, and documented under standardized, auditable procedures with independent QA oversight. The FDA requires GLP for preclinical safety testing that supports the approval of drugs, biologics, and certain devices, with strict rules on how studies are designed, performed, recorded, and reported. This shared emphasis on consistent, reliable data helps regulators make informed decisions about safety and efficacy. Other agencies focus on research funding or welfare standards rather than GLP requirements for regulatory submissions, which is why the combination of EPA and FDA is the correct pairing.