ABSTRACT
Most of the biotechnology industry has not been exposed to the US Food and Drug Administration field organization (the Field), since relatively few products have progressed beyond the research and development stage. This chapter begins with a description of the Field’s involvement in inspections of the emerging biotechnology industry, with emphasis on explaining the FDA’s reasoning and priorities. Generally, the inspectional approach is the same for biopharmaceuticals and traditional chemical drugs. The chapter discusses ways in which a product can become unsafe or ineffective. The good manufacturing practice (GMP) regulations cover the gamut of pharmaceuticals and biopharmaceuticals. In deference to the technical sophistication, speed of innovation, and variety of processes in this industry, the FDA has avoided a “cookbook” approach in the GMP regulations. Instead, it has promulgated broad regulations requiring application under sound scientific principles. Finally, the chapter addresses managerial tools to improve compliance with GMP regulations.
