ABSTRACT
The quality of active pharmaceutical ingredients (APIs) is defined as meeting the appropriate specifications for the API and being produced in a facility compliant with ICH guidelines ‘‘Q7A’’ and FDA’s current good manufacturing practices (cGMPs) regulations. Most countries regulate the manufacture of APIs. These regulations require a total systems approach to assuring an API has the appropriate level of quality. All components in this system must be properly designed, validated, maintained, and operated to allow the manufacturer to assure the API consistently meets quality requirements. The general components of the system are the process, facilities, and the people. This chapter concerns these components, as well as the product quality itself, the regulations, and the quality management (QM) department.
A. The Product
