Abstract:
Tracking, monitoring, and documentation of the manufacturing performance are significant for pharmaceutical companies under the regulations of Food and Drug Administration (FDA). However, the current yield data are not consistent and the business procedures for yield data flow are not unified and optimized at the newly merged pharmaceutical company SJP Singapore. Therefore, a systematic analysis of the current yield data processing was performed in four facilities located at two campuses of this company. Through this analysis, the current business procedures were visualized; the various yield concepts were clearly defined; the problems involved and their root causes were identified; the potential solutions were proposed; and a standard business process was developed taking into account the situation of each facility. As a result, the inconsistent yield data were harmonized and procedures in all four facilities were unified and standardized. This revised business process would enable each department to better fulfill its responsibilities and drive decisions on future improvements.
Description:
Thesis (M. Eng.)--Massachusetts Institute of Technology, Dept. of Mechanical Engineering, 2010.Cataloged from PDF version of thesis.Includes bibliographical references (p. 101-102).
