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.
What this does not cover
stated in the document's own scope- Covers nonclinical (animal/in-vitro) safety studies; clinical studies in humans are governed by Good Clinical Practice (21 CFR 50/56/312 and ICH E6).
- Applies to safety studies supporting applications, not to basic exploratory research or to efficacy studies not intended to support safety claims.
- Sets the quality system for study conduct, not the scientific test methods themselves, which come from the applicable testing guidelines.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
21 CFR Part 58 is the US Good Laboratory Practice regulation for nonclinical laboratory studies — the animal and in-vitro safety studies that support applications for FDA-regulated products. It is a quality-system regulation for study conduct: it defines the role of the study director as the single point of control, establishes an independent Quality Assurance Unit, and requires protocols, standard operating procedures, characterised test articles, controlled specimen and data handling, and archives, all so that a completed study can be reconstructed and trusted years later.
Scope & applicability
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).
Legal basis & how it acquires force
Part 58 is a binding regulation in Title 21 CFR, issued under the Federal Food, Drug, and Cosmetic Act (and, for some product types, the Public Health Service Act). It was promulgated in 1978 after findings of unreliable safety data at contract laboratories. It applies to nonclinical safety studies intended to support a research or marketing application; a study submitted without the required GLP compliance statement, or found not in compliance, can be rejected as unreliable.
Document structure
| Part | Covers |
|---|---|
| Organization and personnel | Study director, Quality Assurance Unit, and personnel responsibilities (Subpart B) |
| Facilities and equipment | Facility design, animal care, and equipment maintenance and calibration (Subparts C–D) |
| Testing facilities operation | Standard operating procedures and reagent/solution controls (Subpart E) |
| Test and control articles | Characterisation, handling, and accountability of test and control articles (Subpart F) |
| Protocol and conduct | The study protocol and the conduct of the nonclinical study (Subpart G) |
| Records and reports | The final report, records retention, and archives (Subpart J) |
Key requirements
- 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
- A final report reflecting the raw data with a signed QAU statement
Implementation tips
- Keep the QAU genuinely independent of study conduct — shared personnel is a frequent citation
- Verify raw-data capture (including instrument printouts and electronic data) is contemporaneous and attributable
Revision notes
FDA has proposed modernizing Part 58 toward a complete "GLP quality system" to better align with OECD GLP; monitor for the final rule.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
Part 58 is closely aligned with the OECD Principles of Good Laboratory Practice, which underpin mutual acceptance of data among OECD member countries — so a GLP study accepted in one jurisdiction is broadly accepted in others. It parallels EPA’s GLP regulations (40 CFR 160/792) for the products those agencies regulate, and it is distinct from the clinical GCP framework that governs human studies.
21 CFR Part 58: frequently asked questions
Quick answers to common questions about 21 CFR Part 58.
What studies does 21 CFR Part 58 apply to?
Nonclinical laboratory studies — animal and in-vitro safety studies — that are intended to support applications for FDA-regulated products. It does not apply to clinical studies in humans, which are governed by Good Clinical Practice.
What is the role of the study director under Part 58?
The study director is the single point of study control, responsible for the technical conduct of the study and for the interpretation, analysis, documentation, and reporting of results. Part 58 vests overall study responsibility in this one role.
How does GLP relate to the OECD GLP Principles?
Part 58 is closely aligned with the OECD Principles of GLP, which enable mutual acceptance of data across OECD countries — so a compliant study is broadly recognised beyond the US.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.