ISPE Drug Shortages Initiative: FAQs

The Drug Shortages Prevention Plan (DSPP) is an actionable plan intended to help the pharmaceutical and biopharmaceutical industry avoid drug shortages that result from manufacturing and quality issues.

ISPE has been at the forefront of this topic going back many years as the prevalence of drug shortages has been found to be increasing in recent years with a notable cause being attributed to manufacturing and facility issues.

ISPE produced its Drug Shortages Prevention Plan (DSPP) for industry built on that data analysis. The DSPP is organized around a “six dimension” framework comprised of these elements: Corporate Quality Culture; Robust Quality System; Metrics; Business Continuity Planning; Communication with Authorities; and Building Capability.