ISPE Announces the Development of a Drug Shortage Prevention Gap Analysis Tool

This week at the ISPE Annual European Conference in Frankfurt, Germany, the society will discuss the Drug Shortage Prevention Gap Analysis Tool which is being developed by the ISPE Drug Shortages Task Team to aid manufacturers in locating gaps in production and quality systems – an important element in solving of shortages in the international supply of medicines. An early draft of the tool will be unveiled on 6 May 2015 at the conference allowing feedback to be gathered and used to refine the tool so that it is an effective and applicable system for ensuring the reliable supply of medicines. “This tool provides manufacturers across the spectrum of the bio/pharmaceutical industry with methods to locate current and future inconsistencies across the pharmaceutical manufacturing supply chain,” said ISPE President and CEO John Bournas. “With this tool, manufacturers will mitigate problems before they arise allowing them to provide an uninterrupted supply of safe, quality medicines to patients worldwide.” The Gap Analysis Tool is the third phase of the ISPE Drug Shortages Prevention initiative. Phase One and Two produced the 2013 survey focused on the manufacturing and quality related causes of drug shortages and the development of the ISPE Drug Shortages Prevention Plan. The six elements outlined in the Drug Shortages Prevention Plan - corporate culture, robust quality systems, metrics, business continuity planning, and communication with health authorities and building capability – are the foundation of the Gap Analysis Tool. For more information about the tool and to view the official press release, please visit the ISPE Newsroom.