Good Laboratory Practice (GLP) is a quality system designed for non-clinical studies concerning the health and environmental safety of various substances. This system dictates how these studies are planned, performed, monitored, recorded, archived, and reported. GLP focuses on the quality and integrity of the data generated, establishing a framework to ensure that laboratory work is structured, traceable, and reliable.
The Core Purpose of Good Laboratory Practice
GLP standards were established to build confidence in the safety data that companies submit to government regulatory agencies. Before GLP regulations, concerns arose about the reliability and integrity of toxicity data provided by manufacturers. These principles created a standardized, auditable framework for conducting safety assessments, designed to prevent data fraud, minimize human error, and ensure accurate documentation of experimental conditions and results.
GLP ensures governments can make informed, evidence-based decisions about public and environmental safety. A GLP study signifies that the data is reproducible and that the study can be fully reconstructed by auditors years later. This reliability is paramount for regulators who must approve products, such as new pharmaceuticals, pesticides, and industrial chemicals, before they enter the market.
Key Principles Governing a GLP Study
A GLP-compliant test facility is structured with defined responsibilities to ensure accountability throughout the study process. The Test Facility Management holds the responsibility for ensuring the facility and personnel meet all GLP requirements, including the provision of adequate resources. A designated Study Director is appointed for each individual study and is the single point of control for the scientific conduct and final report of that study.
One structural component is the Quality Assurance Unit (QAU), which must be independent of the personnel conducting the study. The QAU monitors the study in real-time, auditing protocols, inspecting the facility, and ensuring compliance with all GLP regulations and internal procedures. This separation of duties provides an objective check on the operational aspect of the study.
Standard Operating Procedures (SOPs) provide detailed, written instructions for all routine laboratory activities, from equipment calibration to data handling. All personnel involved must be trained on and adhere to these SOPs, ensuring consistency in how tasks are performed.
Core Requirements
Proper documentation and record-keeping must be maintained for all raw data, protocols, and the final report, allowing for complete data traceability and study reconstruction.
The test facility must be suitable for the work being performed.
All equipment used for generating, measuring, or assessing data must be regularly inspected, maintained, and calibrated against traceable standards.
Types of Non-Clinical Research Requiring GLP
Good Laboratory Practice applies to non-clinical safety testing required for regulatory submissions, which takes place before human trials begin. These studies assess the potential hazards of a substance to human health and the environment, covering toxicology studies that determine adverse effects on a living organism.
Toxicology assessments covered by GLP include studies focused on direct health effects and environmental impact:
Acute toxicity tests, which look at the effects of a single, high dose.
Subchronic toxicity studies, which examine repeated dosing over weeks or months.
Chronic toxicity or carcinogenicity studies, which span a substance’s lifetime.
Genotoxicity studies, which evaluate the potential for a substance to damage genetic material.
Physical-chemical characterization and environmental fate and behavior studies, which assess how the substance degrades and moves through air, soil, and water.
The Regulatory and Global Context
The Organisation for Economic Co-operation and Development (OECD) developed and promoted GLP principles globally, acting as a harmonizing force for international safety standards. The OECD established the Mutual Acceptance of Data (MAD) system, which allows safety data generated under GLP in one member country to be accepted by regulatory authorities in others. This significantly reduces the need for duplicate testing and streamlines international trade.
In the United States, GLP is mandated by the Food and Drug Administration (FDA) for drug and medical device safety testing and the Environmental Protection Agency (EPA) for pesticides and industrial chemicals. GLP is part of a broader regulatory framework that includes related quality systems: Good Manufacturing Practice (GMP) for product production and control, and Good Clinical Practice (GCP) for human clinical trials. GLP is distinct in its focus on the organization and conditions under which non-clinical laboratory safety data is generated.