Glossary Updates12 new terms added to the glossaries · October 2, 2026, 22:44 CEST
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Glossary · GxP: good practices

Good laboratory practice (GLP)

Also known as: GLP, OECD GLP, OECD Principles of Good Laboratory Practice

Good laboratory practice (GLP) is a quality system for the organizational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. It is defined in the OECD Principles of Good Laboratory Practice (1997), applied in the EU through Directive 2004/10/EC and in the USA through 21 CFR Part 58.

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In one sentence

GLP is the quality system for non-clinical safety studies, based on the OECD Principles (1997), Directive 2004/10/EC and US 21 CFR Part 58.

Example

A contract toxicology lab runs a 28-day repeat-dose study under a study plan approved by the study director; its quality assurance unit inspects the study, and raw data, specimens and the final report are archived.

How it applies

  • Scope: Non-clinical safety studies submitted to authorities, such as toxicology studies for medicinal products and chemicals. It does not cover efficacy research or routine analysis.
  • Roles: Each study has one study director with overall responsibility; an independent quality assurance unit inspects studies and facilities; test facility management provides resources.
  • Mutual acceptance: GLP studies from test facilities in the national GLP monitoring programs of OECD members are accepted across member countries under the OECD Mutual Acceptance of Data system.
  • Medical devices: Biological safety studies within the ISO 10993-1 framework are often carried out under GLP, as regulators may expect it for submitted non-clinical data.
  • Technical documentation: Study plan, raw data, standard operating procedures and final report must be kept so that the study can be reconstructed.

GLP vs. ISO/IEC 17025

GLP is a regulatory quality system for individual safety studies and centers on the study director and study reconstruction. ISO/IEC 17025 is a voluntary accreditation standard for the competence of testing and calibration laboratories in general. A lab may hold both, but one does not replace the other.

By knowledge.aitechdoc.world · Published September 25, 2026 · Last reviewed

Source: OECD Principles of Good Laboratory Practice (as revised in 1997); Directive 2004/10/EC; 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies

Definitions follow the cited standards and specifications. Where a source is a copyrighted publication, such as an ISO, IEC or EN standard, the definition is a close paraphrase, not a verbatim quotation, so as not to infringe copyright. We recommend reading the original publication. The sections “How it applies” are editorial commentary by AI TechDoc Knowledge and are not part of any standard.

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