In Force Checked October 24, 2026
Applies to nonclinical safety studies that support FDA research or marketing applications.
What It Covers
How nonclinical laboratory studies are organized, conducted, recorded, and reported so their data can support an FDA application.
Who It Applies To
Testing facilities and sponsors of nonclinical safety studies for drugs, devices, biologics, food additives, and other regulated products.
Key Requirements
- A study director with overall responsibility, and an independent quality assurance unit (§58.33, §58.35).
- Written protocols and standard operating procedures (§58.81, §58.120).
- Equipment, facilities, and test article characterization controlled.
- Raw data, records, and specimens retained and archived (§58.190, §58.195).
What an Auditor Asks to See
- The protocol, raw data, and QA inspection records for a study.
- The archive index and retention records.
Where Systems Fall Short
- QA inspections scheduled around convenience rather than the study’s critical phases.
How QES Helps
GLP readiness reviews of protocols, QA programs, and archives.
Related Standards
Sources. eCFR — 21 CFR Part 58 (opens in a new tab). Status checked October 24, 2026. This page summarizes 21 CFR Part 58; it does not reproduce or replace it. Buy the standard from its publisher, or read the regulation in its official text, before relying on a detail. Not legal advice.