Kim Huynh-Ba Pharmalytik LLC

Kim Huynh-Ba has almost 30 years of experience in quality management system, analytical strategic drug development and stability sciences. She is the Executive Director of Pharmalytik LLC, where she provides consulting and training services to pharmaceutical companies since 2003. Kim is a member of the USP Council of Experts (2015-2025), where she chairs the Chemical Medicines IV Expert Committee, and a member of the USP Expert Panel on Organic Impurities in Drug Substances and Drug Products. We provided support to the PDA to establish the ANSI 0001 standard on “Enhanced Purchasing Controls to Support the Bio-Pharmaceutical, Pharmaceutical, Medical Devices, and Combination Products Industries.” She is on the Governing Board of Eastern Analytical Symposium and was their 2013 President. She was named Fellow with American Association of Pharmaceutical Scientists (AAPS) in 2020.

Kim is an Adjunct Professor at Temple University-School of Pharmacy, Widener University, and Illinois Institute of Technology (IIT) teaching Quality Audit, ICH quality guidelines, GMPs and Pharmaceutical Analysis courses for their master’s programs. She is also a short course instructor on cGMP compliance and quality topics for several global organizations.

Kim has authored over 30 numerous technical publications, book chapters and has spoken extensively, both domestic and internationally. She is the editor of 2 well-known Stability books: the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (2008), “Pharmaceutical Stability Testing to Support Global Markets” (2010), and recently submitted a manuscript entitled “Analytical Chemistry: An Introduction to the Pharmaceutical GMP Laboratory” (in press 2021).