The Good Laboratory Practice standards (GLPs) are federal regulations promulgated in the United States by both the Food and Drug Administration in 21 CFR Part 58 and the Environmental Protection Agency both for FIFRA in 40 CFR Part 160 and for TSCA in 40 CFR Part 792. In Japan, the Ministry for Agriculture, Forestry and Fisheries (MAFF) has also adapted a version of the GLPs.
The Good Laboratory Practice regulations describe the minimal standards for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by FDA or EPA such as animal food additives, human and animal drugs, medical devices for human use, biological products, electronic products, or pesticide products. The regulations do not pertain to studies utilizing human subjects or clinical studies for which the current Good Clinical Practice (cGCP) standards would apply. Nor do the GLPs pertain to basic exploratory studies carried out to determine whether a test article has any potential utility or, for FDA studies only, to determine physical or chemical characteristics of a test article.
In brief generalities and without being comprehensive, the following practices must be adhered to for compliance with the standards:
- A Sponsor is required to notify the testing facility that the study must comply with the GLPs. Personnel records must be available to prove adequate education, training and experience to enable the individual to perform the assigned functions.
- Testing Facility Management must be identified to designate or replace the Study Director, to assure the presence of a Quality Assurance Unit, the characterization of test and control articles, and to assure the presence of adequate personnel, resources, facilities, equipment, materials, and methodologies.
- The Study Director must be designated as the single source of study control who assures that the protocol is approved and followed, that all experimental data are recorded, that the GLPs are followed, and that all raw data, documentation, protocols, specimens, and final reports are archived.
- A Quality Assurance Unit must exist to assure management that facilities, personnel, practices and records are in compliance with regulations, to maintain a master schedule sheet of studies, to inspect each nonclinical study at intervals to assure compliance and to report findings to Study Director and Management, to review the final report to assure that it accurately reflects the raw data, and to prepare and sign a QA statement in the final report.
- Equipment shall have standard operating procedures (SOPs) describing their use, maintenance, and calibration.
- All methods shall have written standard operating procedures. Deviations from the SOPs must be authorized by the Study Director.
- Each study shall have a written Protocol describing the objectives and methods for the conduct of the study.
- Data must be recorded in ink, dated and initialed. Changes in data entries must be as specified.
- The final report shall contain a compliance statement signed by the applicant, the sponsor and the Study Director describing deviations, if any, from the GLP standards.