21 CFR Part 58 - Good Laboratory Practice for Nonclinical Laboratory Studies

What it says

Part 58 establishes Good Laboratory Practice requirements for nonclinical laboratory studies supporting research or marketing permits for FDA-regulated products, covering study protocol design, personnel qualification, facility and equipment standards, quality assurance oversight independent of study conduct, and complete data and record retention.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• GLP governs nonclinical safety and toxicology studies specifically, a fundamentally different scope from GMP's focus on manufacturing, though both frameworks share underlying principles around documentation, independent quality oversight and data integrity.
• An independent quality assurance function, separate from the personnel actually conducting the study, is a defining structural feature of GLP, conceptually similar to quality unit independence in GMP but applied to the research and testing context rather than manufacturing.
• Data supporting a product's eventual regulatory submission, whether an IND, NDA or other application, must trace back to GLP-compliant nonclinical studies where such compliance is required, connecting laboratory research integrity directly to the eventual regulatory approval process.

What FDA inspectors look for

• Whether quality assurance review of nonclinical studies is genuinely independent of the personnel who conducted the study.
• Whether raw study data is retained completely and remains traceable to the specific study, personnel and equipment involved.
• Whether study protocols were followed as written, with deviations documented, consistent with the same fundamental principle underlying GMP deviation management.

Related regulations