ABSTRACT
As we’ve entered the 21st century, regulatory agencies in the United States (Food and Drug Administration, FDA), Europe, and around the world are placing an increased emphasis on the manufacture and control of the active pharmaceutical ingredient (API), or as it has historically been referred to, the bulk drug substance. With the growing requirements for chemistry, manufacturing, and control (CMC) documentation to support an original marketing application, as well as the advent of agency preapproval field inspections, virtually all aspects of the development and scale-up of the API are subject to regulatory review. Additionally, stringent regulations exist, covering changes to
the manufacture and control of the API following approval of the marketing applications, and field inspections are frequently carried out by agencies to ensure ongoing compliance to the marketing application and to current good manufacturing practices (cGMPs).
