Neil Schwarzwalder, B.S., B.A.
Neil Schwarzwalder is Quality Consultant in Compendial Affairs at Eli Lilly and
Company, with 30 years experience in pharmaceutical quality control, developing and
writing analytical methods and coordinating compendial affairs. He has collaborated with
USP and industry groups on many critical issues, including Residual Solvents, Elemental
Impurities, and modernization of USP General Notices.
Publications
J. Mark Wiggins, Janeen Skutnik, Judy Shimek, Neil Schwarzwalder, "Compendial
Issues: A Position Paper on The Ideal Pharmacopeia", Pharmaceutical Technology, Nov
2, 2008
Katherine Ulman, Neil Schwarzwalder, Andrew Teasdale, David Schoneker, Priscilla
Zawislak,“An Industry Perspective on Harmonization and Implementation of ICH and
USP Requirements for Elemental Impurities”, Pharmaceutical Technology, 36:11, Nov 2,
2012.
R. H. Bishara, S. J. Schniepp, B. Ferguson, N. Schwarzwalder, L. Virgili, P. Walsh, M.
Wiggins, J. Kincaid, The USP Revision Process: Recommendations for Enhancements.
Pharmacopoeial Forum 2005; 31(2): 656-661.
Neil A. Schwarzwalder, Rafik H. Bishara. Establishing a Process for Pharmacopoeial
Review and Interaction. American Pharmaceutical Review 2004; 7(4): 53-57.
Affiliations
Member, Midwest Compendial Discussion Group, 1997-present. Co-chair 2004-2006,
2009-2010. (Industry group discussing general compendial issues from perspectives of
innovator, generic, and OTC pharmaceutical manufacturers.)
Chair, USP General Notices Project Team, 2006-2009, 2013-2015. (Groups include
representatives from industry and FDA partnering with USP staff to update general
requirements of the USP.)
Member, USP Residual Solvents Project Team, 2006-2007. (Group including industry
representatives charged with recommending education and revisions to requirements.)
Member, PDA Residual Solvents Task Force, 2006-2007. (Sub-group of the Parenteral
Drug Association recommending actions to address concerns on residual solvents in
pharmaceutical products.) Member and Topic Manager, PDA-USP Planning Committee
for Joint Conference on Residual Solvents, Jan 2007.
Member, USP Compendial Improvements Project Team, 2002-2005. (Group including
industry representatives charged with recommending improvements in processes.
Significant achievements included extending USP implementation dates from 2 months
to 6 months.)
Member, USP Joint Committee for Stakeholder Forums and Project Team
Implementation, 2004. (Committee to establish rules for USP programs for interaction
with industry, FDA, and other stakeholder groups.)