ISPE Debuts 6-Step Tool for Preventing Drug Shortages

The International Society for Pharmaceutical Engineering has launched a drug shortage assessment and prevention tool that helps drugmakers identify risks early on.
The tool assesses potential vulnerabilities across the supply chain and incorporates six key elements to prevent shortages— corporate culture, robust quality systems, metrics, business continuity planning, communication with health authorities and building capability.
The tool provides manufacturers with methods to locate current and future inconsistencies across the supply chain.
Companies also should adopt quality metrics — not only the new ones from the FDA, but personalized metrics that can help determine when a shortage may occur, Fran Zipp, president Lachman Consultant Services and ISPE board member,said Monday while showcasing the plan at the society’s annual meeting in Philadelphia (DID, July 28). These include performance indicators, supply chain reliability and resilience indicators, quality measures and company culture measures, she said.
Companies also should assess each product to understand vulnerabilities and identify areas in which redundancy may be needed. On the basis of that evaluation, a plan should be drawn up for additional capacity and inventory, a second supplier and, if resources allow it, a backup facility, Zipp said. — Kellen Owings

As published in Drug Industry Daily, November 10, 2015