GLP regulations apply to safety assessment for which groups?

• A. Humans only
• B. Animals only
• C. Environment only
• D. Humans, animals, and the environment

Answer: (D)

GLP sets the standard for how safety studies are planned, conducted, recorded, and reported so that the data can be reliably used in regulatory risk assessments. Those assessments guard human health, animal welfare in testing programs, and the environment. In practice, GLP covers nonclinical safety studies that inform human risk and ecological risk alike, with quality assurance, proper documentation, calibrated equipment, and standardized procedures ensuring data integrity from start to submission. Because these studies are meant to protect people, animals used in testing, and ecological systems, GLP applies to safety assessment for all three groups. Limiting it to just humans or just the environment would neglect the data and controls needed to understand animal safety and environmental impact, which is why the correct scope includes humans, animals, and the environment.