ABSTRACT
I. INTRODUCTION This chapter complements its preceding companion chapter 2, which addressed the task of bulk drug process development. The tasks addressed herein overlap the development of the process, as process design does, or culminate the development task, as technology transfer and first manufacture do. As in the previous chapter, this one seeks to provide a sound perspective of the latter tasks to the uninitiated and the new practitioner, while the structured presentation and the deliberately inserted points of view may interest and possibly challenge the experienced practitioner.
