Title 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies, prescribes good laboratory practices (GLP) for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration (FDA). Products may include food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products.

This program supports customers requesting a GLP assessment, as FDA does not provide a certificate of compliance. (This program is not a substitute for regulatory approval.)

ANAB verifies conformance to 21 CFR Part 58, Subparts A-F and J, for laboratory activities and does not review protocols for and conduct of nonclinical laboratory studies or provide regulatory oversight activities of 21 CFR Part 58.

GLP Documents

SR 2432, Supplemental Accreditation Requirements: Good Laboratory Practice for Nonclinical Laboratory Studies, 21 CFR Part 58, Subparts A-F and J (2011)
Addresses organization and personnel, facilities, equipment, testing facilities operation, test and control articles, protocol for and conduct of a nonclinical laboratory study, and records and reports.

FA 2004, Application for ISO/IEC 17025 Accreditation for Testing, Calibration, and Dimensional Measurement Labs

This diagram outlines the ANAB accreditation process:

lab accreditation process

Request a Quote

To learn more about ANAB assessments to 21 CFR Part 58, contact Roger Muse,  414-501-5455.