Good Manufacturing Practice (GMP) describes regulatory requirements and quality standards for manufacturing, testing, releasing, and controlling drugs and biologics.
In clinical development, GMP ensures investigational products are consistently produced with defined identity, strength, purity, and potency. GMP controls help prevent contamination, mix-ups, labeling errors, and stability failures that can compromise participant safety. Quality release testing and deviation management support reliable clinical supply and protocol continuity. GMP compliance is a key indicator of product quality readiness and influences regulatory confidence across development stages.