ABSTRACT
Employment of current good manufacturing practice (CGMP) and approval of a new drug application (NDA) are two pillars of federal law providing support of manufacturing quality for pharmaceutical drug products offered to American consumers in the United States marketplace. These requirements are established in the Federal Food, Drug and Cosmetic Act (FDCA). In this chapter we will discuss these two requirements and how they interface with each other in the FDA programs designed to execute the mandates of the law.
