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Study Reveals Multiple Root Causes for Drug Shortages
Date:6/12/2013

TAMPA, Fla., June 12, 2013 /PRNewswire-USNewswire/ -- Issues within the quality systems of manufacturing were identified as the leading cause of drug shortages by ISPE, the International Society for Pharmaceutical Engineering. Today, this leading organization for technical and regulatory advancements throughout the global pharmaceutical lifecycle released the findings of its 2013 Drug Shortages Survey, which was aimed at identifying the technical, engineering, quality and regulatory issues impacting drug shortages. The study confirmed that drug shortages are multi-factorial, often resulting from issues within the quality systems, which can be affected by key aspects of organizational governance and the quality of interactions with regulatory authorities.

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Earlier this year, ISPE announced its Drug Shortages Initiative and issued a comprehensive survey to industry professionals and companies. The highly complex instrument asked about the technical, engineering, quality, governance and regulatory issues believed to impact drug shortages. ISPE envisions using the results to support industry and regulators in the development of risk-based approaches to mitigating these occurrences.

"This survey reveals many new opportunities for ISPE to lead and support the industry in further dialogue around process improvements that may support drug shortage mitigation while also advancing our collective understanding of the causes of drug shortages," said Nancy S. Berg, ISPE president and CEO. "We look forward to working with our members and regulatory and industry partners to build global solutions for ensuring a reliable supply of medicines. While this study and its findings are significant for the industry and regulatory authorities, it is equally important for e
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