The United States Food and Drug Administration (FDA) can inspect pharmaceutical companies that manufacture FDA-regulated products at any time. They communicate their observations using Form FDA 483 (commonly abbreviated to “483”). 483s tell companies exactly where they need to improve or correct, often highlighting water quality and purification. As both a reagent and product, water is unique in the drug production pathway. This means that its own quality control processes must be as stringent as possible.
Download this guide to learn more about the monitoring and maintenance of water purity in drug discovery, development, and manufacturing processes.
