ISPE Developing Gap Analysis Tool to Help Ensure an Uninterrupted Supply of Medicines

04 May, 2015

International Society for Pharmaceutical Engineering (ISPE) to announce at its Annual European Conference in Frankfurt, Germany, the development of a tool to aid manufacturers in locating gaps in production and quality systems –  an important element in solving of shortages in the international  supply of medicines.

The Drug Shortage Prevention Gap Analysis Tool, being developed by global industry experts known as the ISPE Drug Shortages Task Team, will help prevent today’s global supply chain quality problems that, in recent years, have led to serious shortages of medicines and a negative impact upon patients. An early draft of the tool will be unveiled on 6 May 2015 in Frankfurt. Feedback gathered at the Conference will be 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, communication with health authorities and building capability – are the foundation of the Gap Analysis Tool.

“Input from industry and regulatory stakeholders to the Drug Shortages Prevention Plan resulted in consensus around the need to develop a tool that will enable industry to implement the Plan’s recommendations,” said Francois Sallans, Vice President & Chief Quality Officer, Johnson & Johnson and Chair of the ISPE Drug Shortages Task Team. “We are excited to be able to provide this tool to industry in the very near future.”

For more information on ISPE’s Drug Shortages Initiative, visit or contact Carol Winfield, Director of Regulatory Operations, at

About ISPE

ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Tampa, Florida, USA. Visit for more information.