Which statement correctly describes the focus of GMP, GLP, and GCP?

• A. GMP governs manufacturing; GLP covers nonclinical safety testing; GCP governs ethical and data integrity standards in clinical trials.
• B. GMP governs clinical trials; GLP governs manufacturing; GCP governs packaging.
• C. All three govern financial compliance.
• D. GMP governs distribution; GLP covers marketing; GCP covers labeling.

Answer: (A)

The main idea is that GMP, GLP, and GCP each apply to a different stage of drug development and regulate distinct aspects of quality and safety. GMP governs the manufacturing process, ensuring products are produced and controlled to quality standards with properly validated facilities, equipment, personnel, and documentation. GLP covers nonclinical safety testing, setting standards for how these studies are planned, conducted, and reported to ensure data integrity and reliability. GCP focuses on human clinical trials, emphasizing the protection of participants, ethical conduct, and the integrity and traceability of trial data, including informed consent and ethics committee oversight.

This combination correctly reflects where each framework applies: manufacturing quality under GMP, nonclinical safety study integrity under GLP, and ethical and data integrity standards in clinical trials under GCP. The other options misplace these scopes—for example, assigning clinical trials to GMP, manufacturing to GLP, or labeling and packaging to GCP—so they don’t accurately describe the focus of each standard.