Good laboratory practice (GLP) is the set of rules for how nonclinical laboratory safety studies are planned, run, recorded, reported and archived. In the US it is 21 CFR Part 58, which applies to nonclinical studies that support applications for FDA-regulated products and requires a study director, a quality assurance unit, a final report and archives.
Why it matters when licensing company data
Part 58 requires that raw data, documentation, protocols, final reports and specimens be retained in indexed archives for the shortest of three periods in 58.195(b): 2 years after FDA approval, 5 years after submission, or 2 years after the study ends if it is never submitted. If a testing facility goes out of business, its study records are transferred to the archives of each study's sponsor and FDA is notified.
Because GLP studies are run under protocols, recorded as raw data and reviewed by quality assurance, they are complete, signed accounts of real experiments. Most are run for sponsors, who usually control them; a contract lab's own method validation work is often its own.
See 21 CFR Part 58 explained and assay data at biotechs, CROs and labs.
Example
A contract lab runs a 28-day toxicity study for a sponsor under GLP. The study director signs the final report, quality assurance adds its statement, and the raw data and specimens go to the lab's indexed archive. When the lab later reviews its records, it separates sponsor studies, which the sponsor controls under the services agreement, from its own method validation data, which it may be able to describe.
Source
21 CFR Part 58 (Cornell LII), 58.1 scope. Definition reviewed November 9, 2026 by Origin Data Partners.