Good Laboratory Practices (GLP) are regulations set by the United States Food and Drug Administration (FDA) that establish minimum quality requirements for conducting non-clinical laboratory studies that assess the safety (not efficacy) of FDA-regulated products. These studies are typically used to support research or marketing applications for products such as pharmaceuticals, medial devices, food and color additives, animal drugs, biological products, and electronic products.
GLP regulations appear in Title 21 of the Code of Federal Regulations (CFR), Part 58. For maintenance management purposes, GLP regulations include standards for equipment inspections, cleaning, maintenance, calibration, testing, written standard operating procedures, and recordkeeping.
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