Kim Huynh-Ba
Specialties: Regulatory, GMP, QA/QC
Biography
Kim Huynh-Ba is the Managing Director of Pharmalytik, LLC, a consulting and training organization. She has 30-years experience in the Quality system, GMPs, strategic drug development, analytical and stability sciences. She is a Council of Experts of US Pharmacopeia (2015-2025), where she chairs the Chemical Medicines 4 Expert Committee and a member of the USP Council of Convention.
She chairs the AAPS CMC community, and is a member of the Stability and Pharmaceutical Impurities communities. She was named AAPS Fellow in 2020 and part of AAPS PharmSci Scientific Program Committee. She is a member of the AAPS Open Editorial Board and Institute of Validation Technology Editorial Board.
As an advocate educator, Kim is an Adjunct Professor at Temple University-School of Pharmacy and Illinois Institute of Technology, where she teaches Good Manufacturing Practices, Quality Audit, ICH quality guidelines, and Pharmaceutical Analysis. She authored over 40 publications and book chapters. She is the editor of the two well-known stability books -“Handbook of Stability Testing of Pharmaceutical products” and “Stability Testing to support Global Markets.”, and recently completed a new book entitled “Analytical Testing for the Pharmaceutical GMP Laboratories.”