2nd Excipient Workshop: Focus on Excipient Quality, Compendial Testing, and Regulatory Impact

USP has resolved to bring its compendia, the United States Pharmacopeia—National Formulary (USP–NF), up to date by 2020. The objective of this initiative is to develop standards that reflect "state-of-the-industry" techniques for sufficiently monitoring drug quality, purity, and strength. This includes an effort to ensure that all monographs in the USP–NF—including those for excipients—are current, relevant, and suitable for their intended use.

USP has made tremendous progress in modernizing outdated methodologies in the USP–NF through collaborative efforts with FDA and its stakeholders working together to enhance global health through the improvement of public quality standards. A high priority is to update inadequate excipient identification tests that add to the risk created by a very complex global supply chain. Under FDA’s cGMP for Drugs; 21 CFR § 211.84(d)(l) Control of Components (Subpart E), pharmaceutical drug manufacturers must perform at least one test to verify the identity of each component of a drug product. New and updated monograph quality specifications helps improve testing controls and provide tools to qualify an excipient for intended use.

Come and experience the collaborative opportunity USP workshops provide and share your thoughts and ideas on this important topic with peers and USP experts.

The USP Workshop will offer participants an opportunity to discuss the recent excipient monograph modernization and harmonization activities and the challenges faced in developing new and updated monographs fit for their pharmaceutical intended purposes. This includes identifying gaps in existing excipient monograph specifications for use in Biologic drugs where compendial tests are not adequate to control the quality of the excipient or its intended purpose as seen in the FDA’s Inactive Ingredient Database. The workshop breakout sessions will engage stakeholder sponsorship in understanding the definition of excipient as a component in terms of processing aids vs appearing in the final biologic drug products and the regulatory definition of Raw and Ancillary materials.



Hear from experts in industry, academia, and governments discuss excipient topics over a two-day workshop.

Workshop Objectives

  1. To understand how USP and FDA work together to update excipient monographs
  2. Learn about USP-NF up-to-date strategies for excipient monographs by 2020
  3. Have an impact on USP-NF up-to-date for excipient monographs
  4. Influence and understand the future direction of USP-NF excipients and “fit for purpose”
  5. Share your ideas on excipients up-to-date strategy
  6. Understand the challenges and opportunities in development of Novel Excipients and NF monographs
  7. Understand when compendial grade materials are necessary in the manufacture of Biologics
  8. Meet USP Expert Committee members and FDA, EDQM and PMDA staff that work with excipients
  9. Network with colleagues, and with fellow excipients/raw materials industry professionals
  10. Benchmarking raw material and excipient practices with industry

Who Should Participate

  • Formulation scientists
  • Analytical chemists
  • QA/QC analysts
  • R&D scientists, managers
  • Excipient Manufacturing scientists, managers
  • Excipient distributors
  • Pharmaceutical manufacturing scientists, managers
  • Procurement managers
  • Regulatory scientists
  • Contract research organizations
  • Contract manufacturing organizations

Related Links On USP.ORG

Workshop Steering Committee

  • Eric J. Munson, Ph.D., Professor, Pharmaceutical Science, University of Kentucky, Chair, Excipient Expert Committee 1
  • Lawrence H. Block, Ph.D., Emeritus Professor of Pharmaceutics, Division of Pharmaceutical Sciences, Excipient Expert Committee 2 Member, General Chapters Physical Analysis member
  • Richard C. Moreton, Ph.D., Vice President, Pharmaceutical Sciences, FinnBrit Consulting, Excipient Expert Committee 1, Member
  • Jiasheng Tu, Ph.D., Professor, Department of Pharmaceutics, China Pharmaceutical University, Excipient Expert Committee 2 Member
  • Kathy Demarest, Executive Director, QC Labs, Amgen
  • Edwin R. Fleischer, Head of Direct Materials, Global Biologic Quality Control, Genentech
  • John Punzi, Ph.D., Director, Quality Assurance and Technical Affairs, Consumer Healthcare Products Association
  • Phillis Walsh, Associate Director, Compendial Affairs, Merck
  • Priscilla Zawislak, Global Regulatory Affairs Manager, Pharmaceutical and Nutritional Ingredients, Ashland
  • Steven Wolfgang, Ph.D., Acting Associate Director, CDER, FDA
  • Jeffrey Medwid, Ph.D. , Senior MC Quality Review Chemist, FDA


  • Catherine Sheehan, M.S., M.S., Senior Director, Excipients, USP
  • Fouad Atouf, Ph.D., Director, Biologics and Biotechnology, USP
  • Tong (“Jenny”) Liu, Ph.D., Scientific Liaison, Excipients, USP
  • Richard Lew, M.S., Expert Committee Manager