GLP (Good Laboratory Practice)
Quick facts
| Category | Non-clinical laboratory study integrity standard |
|---|---|
| Used by | Pharmaceutical, chemical, biotechnology and environmental testing laboratories |
| Also called | GLP |
| Related standards | GxP Compliance, ISO 17025 |
| Related processes | Calibration management, data integrity, document control, employee training management |
| Semantic match | GLP, Good Laboratory Practice, non-clinical study data integrity, laboratory study reliability |
What is GLP (Good Laboratory Practice)?
GLP focuses specifically on non-clinical laboratory studies, the research conducted on chemical, biological or pharmaceutical substances before any human testing begins, ensuring that resulting data is scientifically reliable and reproducible enough to support regulatory decision-making.
GLP requirements cover the full lifecycle of a study: how it is planned, the conditions under which it is performed, ongoing monitoring during the study, accurate recording of results, proper archiving of records and materials, and complete reporting of findings.
Because GLP data often supports critical safety decisions, such as whether a new drug is safe enough to proceed to human clinical trials, regulatory authorities require adherence to GLP as a condition for accepting non-clinical safety data in regulatory submissions.
Why is GLP (Good Laboratory Practice) important?
GLP ensures that early-stage safety data, which forms the foundation for decisions about whether to proceed with human testing, is trustworthy and can withstand regulatory scrutiny.
Without GLP compliance, non-clinical study data may not be accepted by regulatory authorities, potentially requiring costly and time-consuming study repetition before a product can advance through development.
GLP's emphasis on equipment calibration and personnel qualifications reflects the reality that unreliable measurement or unqualified personnel can undermine the validity of study results just as much as flawed study design.
How does GLP (Good Laboratory Practice) work?
GLP's core requirement areas include:
- Study planning. Develop a detailed study protocol before work begins.
- Test substance control. Characterize and control test substances used in the study.
- Personnel qualifications. Ensure staff conducting the study are appropriately trained and qualified.
- Equipment calibration. Maintain and calibrate laboratory equipment used in the study.
- Quality assurance. Implement independent quality assurance oversight of study conduct.
- Documentation and archiving. Record, archive and report study data completely and accurately.
GLP vs. GCP
| Comparison | GLP | GCP |
|---|---|---|
| Applies to | Non-clinical laboratory studies | Clinical trials involving human subjects |
| Development stage | Pre-clinical research | Human clinical testing |
Real-world examples of GLP (Good Laboratory Practice)
A contract research organization conducts a non-clinical toxicology study under GLP conditions, maintaining detailed protocols and records to support a pharmaceutical sponsor's regulatory submission.
A chemical company performs environmental safety testing under GLP, ensuring the resulting data meets the reliability standards regulatory authorities require for product registration.
A laboratory's independent quality assurance unit reviews an ongoing GLP study, verifying that the protocol is being followed and identifying any deviations requiring correction.
Regulations and standards related to GLP (Good Laboratory Practice)
GLP requirements are defined in regulations such as FDA 21 CFR Part 58 in the United States, alongside similar international frameworks, and are a prerequisite for regulatory authorities to accept non-clinical safety data supporting product development and registration.
GLP differs from GCP, which specifically addresses clinical trials involving human subjects, and from GMP, which addresses manufacturing; each discipline covers a different, non-overlapping stage of the product development and lifecycle process.
How QT9 helps with GLP (Good Laboratory Practice)
QT9 QMS capabilities supporting GLP compliance
- Maintain calibration records for laboratory equipment used in GLP studies.
- Support document control for study protocols and reports.
- Track personnel training and qualifications for laboratory staff.
- Maintain complete, timestamped audit trails supporting data integrity.
- Provide pre-validated documentation to support GLP compliance efforts.
- Connect laboratory quality data with broader organizational QMS processes.
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Common mistakes with GLP (Good Laboratory Practice)
Common mistakes include inadequate documentation of study deviations, which can undermine the credibility of otherwise sound study data during regulatory review.
Other problems include failing to maintain independent quality assurance oversight separate from the study conduct team, weakening the objectivity GLP is designed to ensure.
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