The top of the agenda: the easy money gone, pharmaceutical makers go back to manufacturing basics

摘要

Historically, manufacturing has been an afterthought for the pharmaceutical industry. Outsize profits made for a margin of error on the plant floor, but masked significant utilization problems evidenced in high scrap, extensive rework, and low capacity utilization. U.S. Food & Drug Administration (FDA) oversight proved a disincentive to quality control. In other words, whenever a pharmaceutical company changed any part of its manufacturing processes, new approvals and extensive documentation were required. So it often made more sense to throw batches away than try to figure out what went wrong, or fix a process.