What is the difference between GMP for manufacturing and GLP for preclinical studies?

• A. GMP governs clinical trial design; GLP governs post-market surveillance.
• B. GMP applies only to packaging; GLP applies to labeling.
• C. GMP ensures quality of manufactured products; GLP ensures reliability and quality of nonclinical safety studies.
• D. GMP ensures patient satisfaction; GLP ensures marketability.

Answer: (C)

The difference centers on what each set of standards regulates: manufacturing quality versus data integrity for safety studies. Good Manufacturing Practice ensures that the products are made to consistent quality, with strict controls on facilities, equipment, processes, materials, and documentation so that each batch meets predefined quality attributes. Good Laboratory Practice focuses on the planning, conduct, reporting, and reliability of nonclinical safety studies, ensuring that study design, execution, data collection, and analysis produce trustworthy results that support regulatory decisions.

So the statement that GMP ensures quality of manufactured products and GLP ensures reliability and quality of nonclinical safety studies is the accurate description. The other choices mix up scope—GMP doesn’t govern clinical trial design or post-market surveillance, GLP isn’t about labeling or packaging, and neither GMP nor GLP is about patient satisfaction or marketability.