International Society for Pharmaceutical Engineering (ISPE) at its Annual Meeting in Philadelphia, Pennsylvania, USA, announced the development of a tool that provides a structured approach for industry to develop strategies and practices for each of the six drug shortage dimensions, and employs a holistic approach to identifying potential vulnerabilities within the industry and supply chains.
The ISPE drug shortage assessment and prevention tool will aide manufacturers in locating gaps between their current operations and the desired state of a reliable supply of quality pharmaceuticals. The tool is a self-assessment process that facilitates improvements across supply chains and increases supply reliability in these six areas namely building capability, corporate culture, business continuity planning, robust quality systems, metrics and communication with regulatory authorities.
This tool will enable companies to address supply chain risks with a common framework, no matter their size, capability or location.
The tool, developed by the ISPE Drug Shortages Task Team, builds on the best practices described in the ISPE Drug Shortages Prevention Plan published by ISPE in 2014. The task team has assembled a holistic contribution to support a better understanding of industry and supply partner weaknesses, and provide concrete steps to put continuous improvement plans into action.
The tool training will roll-out in phases through-out 2016, kicking off with introductory webinars in the first quarter. The next phase will include a two-day classroom training experience and the final phase will launch on-demand training classes online.