Production standards are a critical factor in pharmaceutical manufacturing. Incidents such as the outbreak at the New England Compounding Center in 2012 (which resulted in more than 50 deaths and over ~750 infections) and the Valsartan recall of 2018 have underscored the importance of food and drug manufacturers adhering to the highest possible manufacturing standards. Such events have also stressed the need for strong regulations and have prompted the development and enforcement of Good Manufacturing Practice (GMP).

GMP (or Current Good Manufacturing Practice [cGMP] in the US) provides a framework that helps strengthen manufacturing processes by ensuring manufacturing facilities and processes focus on quality and consistency. Unlike International Organization for Standardization (ISO) standards, which encompass a broader scope, GMP focuses on specific industries such as food, cosmetics, and pharmaceuticals. 

This Insight takes an in-depth look at what GMP regulations are, how they are enforced across the world, how they have evolved in the US, and how they are redefining manufacturing processes, focused on the pharmaceutical industry.