ABSTRACT
I. INTRODUCTION The intent of the preceding chapter was to briefly outline the requirements and general expectations related to the active pharmaceutical ingredient (API) for submitting and maintaining the Chemistry, Manufacturing, and Control (CMC) sections of both investigational and marketing applications. I hope this work adequately conveys the importance of this activity to a company, as well as the complexities for both the company and the reviewing agencies. This chapter will focus on tools and strategies that are available to support this critical function. Much of the information will be shared through Web links to appropriate sites containing the actual guidance documents. These links are accurate as of the authoring of this chapter in early 2009.
