Regulatory Approaches for Supporting Innovation in Pharmaceutical Manufacturing
Posted on March 4, 2016
By: Sau (Larry) Lee, Ph.D., Associate Director for Science
Xiaochuan Yang, Ph.D., Visiting Associate
Geng Tian, Ph.D., ORISE Fellow
Thomas O’Connor, Ph.D., Chemical Engineer
Office of Pharmaceutical Quality
Center for Drug Evaluation and Research
Food and Drug Administration
Introduction When quality issues arise in manufacturing facilities, product recalls and plant shutdowns may follow, potentially resulting in drug shortages. By far, the most frequently cited reason – approximately 65 percent – for drug shortages relate to manufacturing and quality issues1. There...
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Related Topics and Keywords
3-D printing technologies, Continuous Manufacturing, Continuous Processing, drug quality and shortage, emerging technologies, Geng Tian, improved quality, increased efficiency, Modernizing manufacturing technology, Office of Pharmaceutical Quality, OPQ, plant shutdowns, product recalls, reduced product failures, Sau (Larry) Lee, single-use, Thomas O’Connor, Xiaochuan Yang
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