Current Good Manufacturing Practice and the Drug Approval Process

INTRODUCTION 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 U.S. 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 interfacewith each other in the FDAprograms designed to execute the mandates of the law.