Definition · Plain-language
Good Laboratory Practice (GLP)
Good Laboratory Practice (GLP) is the quality system that governs how non-clinical safety studies are planned, performed, monitored, recorded, reported and archived, so their results can be trusted by regulators.
The step most authors miss
Doing CRediT right? Don’t stop at the statement.
A CRediT statement credits you inside one paper. The recognition CRediT was built for happens when those roles are tied to you, persistently. Sign in with your ORCID — free — and claim your CRediT contributions on casrai.org, the home of the standard. They become a verified, portable part of your identity, not a line that disappears into one PDF.
Free: claim your contributions, then export a journal-ready CRediT statement, schema.org structured data, JATS XML, CSV or BibTeX — and preview your public profile. A membership publishes that profile publicly and verifies the journals you serve.
What GLP applies to
GLP applies to non-clinical safety studies — typically laboratory or animal toxicology, pharmacology and environmental-fate studies — whose results support the safety assessment of pharmaceuticals, chemicals, pesticides and food additives. Importantly, GLP is about the management and conduct of the study rather than the scientific merit of the test method itself. It ensures that whatever method is used, the work is properly planned, faithfully executed and fully documented so that a study can be reconstructed years later from its records.
Key GLP roles and controls
A GLP study is led by a single Study Director who has overall responsibility for its conduct and final report. An independent Quality Assurance Unit (QAU) monitors the study against the approved protocol and standard operating procedures, but does not report to the Study Director, preserving objectivity. Raw data, specimens and the final report must be retained in a controlled archive. These structural safeguards — clear accountability, independent oversight and complete archiving — distinguish GLP from ordinary good laboratory housekeeping.
GLP is not the same as accredited testing
GLP is frequently confused with laboratory accreditation standards such as ISO/IEC 17025, but the two have different aims. ISO/IEC 17025 demonstrates a laboratory’s technical competence to produce valid results for routine testing. GLP, by contrast, governs the integrity and traceability of data generated in specific non-clinical safety studies for regulatory submission. A laboratory may need one, the other or both depending on the work it performs.
Key facts
At a glance
- Definition: quality system for the conduct and reporting of non-clinical safety studies
- Scope: study management and documentation, not the scientific test method itself
- US regulation: FDA 21 CFR Part 58
- International basis: OECD Principles of Good Laboratory Practice
- Key roles: Study Director and independent Quality Assurance Unit
- Goal: reliable, reconstructable, archivable safety data for regulators
Common misconceptions
What people often get wrong
Often heard: GLP is the same as ISO/IEC 17025 laboratory accreditation.
Actually: They serve different purposes. ISO/IEC 17025 demonstrates technical competence for routine testing, whereas GLP governs the integrity and traceability of data from specific non-clinical safety studies for regulatory submission. A lab may need either or both.
Often heard: GLP judges whether a study used scientifically sound methods.
Actually: GLP concerns how a study is managed, conducted, recorded and archived — not the scientific validity of the chosen method. It ensures the work is reconstructable and the data trustworthy, irrespective of the method’s merits.
Often heard: GLP applies to clinical trials in patients.
Actually: Clinical trials in human subjects are governed by Good Clinical Practice (GCP), not GLP. GLP covers non-clinical safety studies, typically laboratory and animal work, that precede or support clinical development.
Going deeper
