Usage Examples
- The pivotal 28-day tox study was run under GLP at a qualified testing facility.
- The QAU statement in the final report is missing the inspection dates.
- That mechanistic study was non-GLP by design, so it informs interpretation but does not carry the safety conclusion.
What is Good Laboratory Practice (GLP)?
Good Laboratory Practice is the FDA quality system at 21 CFR Part 58 governing nonclinical safety studies submitted for research or marketing permits, distinguishing pivotal toxicology work from exploratory laboratory research that carries no such obligations.
Good Laboratory Practice exists because FDA reviewers never watch the toxicology study happen. They read a report years later and decide whether a human can be dosed. Part 58 therefore regulates the conditions under which nonclinical safety data is generated, recorded, and archived, so that a reconstruction from the raw data can either confirm the conclusion or expose it.
Good Laboratory Practice covers nonclinical laboratory studies that support or are intended to support applications for research or marketing permits: in vivo or in vitro experiments in which test articles are studied prospectively to determine their safety. GLP does not reach efficacy or exploratory work never offered in support of a permit, nor clinical trials or commercial manufacturing, which sit under GCP and GMP.
Good Laboratory Practice is applied through two named accountabilities. A study director carries overall responsibility for the technical conduct of the study and for the interpretation, analysis, documentation, and reporting of results. A quality assurance unit signs a statement included with the final report specifying the dates inspections were made and the findings reported to management and to the study director.
Not to be confused with
- GMP
- GMP governs the manufacture of drug substances and drug products. GLP governs the safety studies that justify dosing a human in the first place. A contract testing facility can be fully GLP compliant and hold no GMP status at all.
- GCP
- GCP begins when a human is enrolled; GLP ends there. The tox package that supports the IND is GLP work, and the trial the IND authorizes is GCP work, under a different regulation and a different inspection assignment.
- OECD GLP
- Part 58 binds only studies supporting or intended to support applications for FDA research or marketing permits. A study run to OECD principles is not automatically a Part 58 study, and a US filing is judged against Part 58.
- Data integrity
- data integrity is an attribute the raw data and archived records must carry. GLP is the organizational system that produces them. A study can have clean audit trails and still fail Part 58 for a missing quality assurance unit statement.
The obligations below are the ones that decide whether a report is accepted as GLP.
What you must do
- 1Determine, before the protocol is signed, whether the study supports or is intended to support an application for a research or marketing permit, because that is what pulls it into Part 5821 CFR 58.1
- 2Designate a study director who holds overall responsibility for the technical conduct of the study and for the interpretation, analysis, documentation, and reporting of results21 CFR 58.33
- 3Have the quality assurance unit prepare and sign a statement specifying the dates inspections were made and the findings reported to management and to the study director21 CFR 58.35(b)(7)
- 4Include that signed quality assurance unit statement in the final study report21 CFR 58.185
- 5Retain documentation records, raw data, and specimens in the archive for whichever of three periods is shortest: two years after FDA approves the application the study supported, five years after the results are submitted to FDA in support of an application, or two years after the study is completed, terminated, or discontinued21 CFR 58.195(b)
Common mistakes
Calling a study "GLP-like" or compliant in spirit
Part 58 gives no partial credit. A final report without the signed quality assurance unit statement required by 58.185 is not a GLP report, whatever the science looked like. The cost lands as a repeated pivotal study sitting directly on the critical path to first-in-human dosing.
Deciding GLP status after the data exists
Scope under 58.1 turns on whether the study supports or is intended to support a permit application, which is a call made before the protocol is signed. Teams that run a pivotal tox study non-GLP to save money find out at IND assembly, and the study cannot be retro-qualified.
Archiving to a single flat retention clock
58.195(b) sets retention to the shortest of three periods, and the trigger differs depending on whether the study was submitted and whether the application was approved. One blanket rule either destroys records that are still required or pays storage on records that are not.
When This Matters
- The pivotal 28-day tox study was run under GLP at a qualified testing facility.
- The QAU statement in the final report is missing the inspection dates.
- That mechanistic study was non-GLP by design, so it informs interpretation but does not carry the safety conclusion.
Frequently Asked Questions
GLP applies to nonclinical laboratory studies that support or are intended to support an application for a research or marketing permit, meaning the pivotal toxicology and safety work behind an IND or NDA. Part 58 defines those studies as in vivo or in vitro experiments testing articles prospectively to determine their safety.
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