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Two ISPE Studies Cited in FDA Statement to Congress
Date:12/20/2013

lopment of new manufacturing technologies as a means of ensuring the availability of safe and effective medicines,” said Nancy S. Berg, President and CEO of ISPE. “The development and adoption of new and novel manufacturing technologies such as continuous manufacturing requires close collaboration and communication between the pharmaceutical industry and global regulators. As a neutral organization focused on product quality important to patient safety, we are pleased to provide the FDA with reliable, authoritative, scientific technical data and experience. We look forward to continued collaboration with the FDA to modernize manufacturing methods.”

Published in June 2013, ISPE’s Drug Shortages Survey report is available at http://www.ISPE.org/Drug-Shortages/2013JuneReport. The report also was cited in the FDA’s Strategic Plan for Preventing and Mitigating Drug Shortages published in October. ISPE plans to deliver additional updates during 2014.

A summary of the Business Benefits of Quality by Design (QbD) survey conducted by the ISPE United Kingdom Affiliate’s PAT Community of Practice was published in the July-August 2012 issue of Pharmaceutical Engineering magazine.
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