Good Laboratory Practice for Nonclinical Laboratory Studies
The US regulation prescribing good laboratory practices for nonclinical (animal and in-vitro) safety studies that support applications for FDA-regulated products. Part 58 establishes the roles of the study director and Quality Assurance Unit, protocol and SOP control, specimen and data archiving, and the reconstructability of study conduct.
Nonclinical laboratory safety studies intended to support research or marketing applications to the FDA. Does not apply to clinical studies (GCP) or routine QC testing (GMP).
- 01A single study director responsible for overall study conduct and interpretation
- 02An independent Quality Assurance Unit maintaining the master schedule and inspecting studies
- 03Approved protocol and SOPs governing every study operation
- 04Complete, attributable raw data retained and archived for the required retention period
- 05A final report reflecting the raw data with a signed QAU statement
FDA has proposed modernizing Part 58 toward a complete "GLP quality system" to better align with OECD GLP; monitor for the final rule.
21 CFR Part 58: frequently asked questions
Quick answers to common questions about 21 CFR Part 58.
What is 21 CFR Part 58?
21 CFR Part 58 — Good Laboratory Practice for Nonclinical Laboratory Studies — is a regulation issued by the Food and Drug Administration (United States). The US regulation prescribing good laboratory practices for nonclinical (animal and in-vitro) safety studies that support applications for FDA-regulated products. Part 58 establishes the roles of the study director and Quality Assurance Unit, protocol and SOP control, specimen and data archiving, and the reconstructability of study conduct.
Who does 21 CFR Part 58 apply to?
Nonclinical laboratory safety studies intended to support research or marketing applications to the FDA. Does not apply to clinical studies (GCP) or routine QC testing (GMP).
What are the key requirements of 21 CFR Part 58?
FDA 21 CFR Part 58 requires, among other things: A single study director responsible for overall study conduct and interpretation; An independent Quality Assurance Unit maintaining the master schedule and inspecting studies; Approved protocol and SOPs governing every study operation; Complete, attributable raw data retained and archived for the required retention period.
When was 21 CFR Part 58 last updated?
The current version of 21 CFR Part 58 dates from January 2023. FDA has proposed modernizing Part 58 toward a complete "GLP quality system" to better align with OECD GLP; monitor for the final rule.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
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When 21 CFR Part 58 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.