21 CFR Part 58 – Good Laboratory Practice (GLP)

This topic is part of the SG Systems Global regulatory glossary series.

Updated October 2025 • FDA / GLP • Nonclinical Laboratory Studies

21 CFR Part 58 establishes FDA Good Laboratory Practice (GLP) regulations for nonclinical laboratory studies that support research or marketing applications for drugs, biologics, devices, or food additives. GLP ensures the quality, integrity, and traceability of data used to evaluate product safety before human use or clinical trials.

“GLP is about data integrity in the lab — every sample, test, and result must be reconstructable and traceable from plan to archive.”

1) What It Is

GLP rules apply to all nonclinical laboratory safety studies conducted for FDA submission. They set requirements for organization, personnel qualification, facilities, equipment, protocols, records, and archival practices. The goal is to prevent data fabrication, selective reporting, and loss of raw records.

Scope & application. Applies to laboratories performing animal toxicity, pharmacology, or safety testing for drugs, biologics, medical devices, or food additives. Does not apply to basic research or clinical trials.

Selected sections of Part 58:

• 58.29 Personnel & Organization. Qualified study directors, quality assurance (QA) units, and defined responsibilities.
• 58.41–51 Facilities & Equipment. Adequate design, maintenance, calibration, and cleaning procedures for equipment.
• 58.81–83 Protocols & Conduct. Study plans, amendments, and raw data collection under controlled conditions.
• 58.120–130 Records & Reports. Signed final reports, retention of raw data, specimens, and QA audits.
• 58.190 Archiving. Secure storage of study records and materials for FDA inspection.

Electronic record controls. If nonclinical data are electronic, Part 11 requirements apply for system validation, audit trails, and e-signatures.

Relation to other rules. Links to Parts 210/211 (drug GMP), 820 (device QSR), and 600–680 (biologics).

2) FAQ

Q1. Who must follow GLP?
Any nonclinical testing facility generating safety data for FDA submission under 21 CFR Parts 312, 511, or 58.

Q2. Does GLP apply to R&D labs?
Only if the work supports regulated nonclinical studies — exploratory R&D is usually exempt.

Q3. What is a QA unit?
An independent group responsible for inspecting studies and reporting findings to management and the study director.

Q4. Can data be stored digitally?
Yes, but electronic systems must comply with Part 11 for validation, audit trails, and e-signatures.

Q5. How do GLP and GMP differ?
GLP covers nonclinical research data integrity; GMP covers commercial manufacturing and product quality.

Q6. Where can I read the full rule?
See 21 CFR Part 58 (eCFR).

3) How It Relates to V5

V5 by SG Systems Global supports GLP laboratories by digitally enforcing protocol controls, sample tracking, data review, and Part 11 compliance.

• Sample & test traceability. LIMS Scheduling tracks samples, tests, and results to study IDs and archives.
• Data integrity. Part 11 audit trails and e-signatures ensure raw data are secure and reviewable.
• Equipment & calibration. Integrates maintenance logs with the QMS for calibration and preventive maintenance records.
• Protocol management. Digitized study plans, version control, and amendments tracked to user IDs.
• Deviation & CAPA. Automatic routing of non-conformances to QMS for investigation and closure.
• Integration & reporting. V5 Connect API links GLP data with ERP and reporting systems.

End-to-end example. A preclinical tox lab uses V5 to generate sample labels, log test data, store electronic raw records under Part 11, and trigger QA audits — creating a defensible GLP archive for FDA submission.

Primary References:
• FDA eCFR: 21 CFR Part 58
• Electronic Records: 21 CFR Part 11
• Drug & Device GMP: 21 CFR 210/211, 21 CFR 820