Implementation of new technology in a regulated environment

Abstract

This thesis investigates potential improvements to the manufacturing process through the implementation of process analytical technologies (PAT) in the heavily regulated pharmaceutical industry. The thesis focuses on the identification, prioritization, evaluation, and implementation of Process Analytical Technologies (PAT's) to solve manufacturing issues. While full implementation of a solution is not a part of this thesis, development of an implementation plan is. In parallel to executing these four stages of the project, processes and tools for the assessment of future PAT ideas are developed. The ideas developed in this thesis were tested in an industrial setting, and several case studies are included from this work. Key results are that a rigorous business evaluation of a potential project from a financial and intangible viewpoint is necessary, that PAT can improve the efficiency of a manufacturing process both at the unit operation and entire system levels, and that the organizational structure of a pharmaceutical company and the regulatory authority will have to change in order to support the integration of PAT into the manufacturing plant. Ramifications of the new technology on the organization are presented along with recommendations for organizational change to better utilize PAT.