Good Laboratory Practice (GLP)
A regulatory quality framework governing how nonclinical safety studies are planned, conducted, recorded, and reported to ensure data integrity and reliability. Required for preclinical toxicology submissions, GLP supports the credibility of data used in drug and device approvals.
What is Good Laboratory Practice (GLP)?
Good Laboratory Practice (GLP) is a regulatory quality framework that governs how nonclinical safety studies are planned, conducted, recorded, archived, and reported. Its purpose is to ensure that the resulting data are reliable, traceable, and reconstructable.
GLP applies to preclinical work such as toxicology studies that support drug and device development. It sets expectations for study design, personnel responsibilities, equipment, documentation, and quality assurance oversight.
Why is GLP important?
GLP gives regulators confidence that safety data submitted in support of a drug or device were generated under controlled, well-documented conditions. This credibility is essential because early safety findings inform decisions about whether and how a product proceeds to human testing.
Because GLP emphasizes data integrity and full documentation, it underpins the trustworthiness of the evidence used in regulatory review. Lapses can undermine an entire submission, which is why adherence is taken seriously throughout preclinical research.
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