Chapter 14: Technology Transfer of an Active Pharmaceutical Ingredient

Often the culmination of process development activity is the transfer of the chemical process to facilities for the manufacture of late phase or commercial launch stocks. Technology transfer is a critical business process, often overlooked in transforming a process from the laboratory to full manufacturing scale. Whether moving a process within the same site as development activity, to another site within the same company or to a separate manufacturing partner in a separate country, technology transfer remains an important step and one which, without proper preparation, can lead to significant delays to the delivery of valued medicine to patients. In this chapter we discuss how to successfully manage process technology transfer and suggest a stepwise approach covering the key elements of moving a process from one site to another.