USP and the Future –Technology and the Modern Compendium of Standards

Tina S. Morris, Compendial Science, USP- United States Pharmacopeia, MD, USA (reutl@bioforum.co.il)

As the United States Pharmacoepeia (USP) prepares for its 200^th anniversary in 2020, significant developments are underway to prepare our compendium of standards for the future and assure continued relevance and positive impact on medicine quality. Not just the launch of USP’s powerful new USP-NF online platform in the spring of 2018, but also the comprehensive and strategic approach to our content structure of chapters and monographs, the “compendial architecture” are critical elements in best leveraging USP’s format and content to the rapid and flexible introduction of standards for new technology needs. As new and potentially disruptive trends in pharmaceutical manufacturing and analytical science challenge traditional quality paradigms, standards will be a critical element in supporting method and technology transitions. 

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Short Biography of Presenting Author

Tina Morris, Ph.D., is Senior Vice President, Science—Compendial Science, for USP.  She leads USP’s overall compendial science and architecture strategy, including USP’s General Chapter development, as well as International Pharmacopeial Collaboration and Harmonization activities. As part of USP’s up-to-date efforts, she leads a cross-functional effort at USP aimed at continuously improving USP’s science and policy approaches. Previously, Dr. Morris led USP’s Global Biologics department. Prior to joining USP in 2003, Dr. Morris held positions at a number of biotechnology companies in the areas of analytical development for biologics and biotechnology products--particularly mass spectrometry and recombinant protein characterization. Dr. Morris holds several U.S. patents in the areas of virology and mass spectrometry assay development. Dr. Morris completed her postdoctoral fellowship at the National Institutes of Health and earned a Ph.D. in Molecular Virology from the University of Lübeck, Germany. She is the author of many publications in peer-reviewed journals and a frequent speaker at national and international scientific conferences