A Practical Guide to the New Global Directives on Elemental Impurities in Drug Products and Pharmaceutical Materials
Scientists in the pharma industry who are responsible for running the new plasma spectrochemical based procedures for the measurement of elemental impurities in drug products. Appropriate not only for new users, but also for those who have had some experience in running the new methods and have questions. Attendees should have a basic knowledge of ICP-MS.
The aim of the course is to provide a basic understanding and practical perspectives of the new elemental impurity permitted daily exposure (PDE) levels and analytical methodologies described in USP Chapters <232>, <233> and ICH Q3D Step 4 Guidelines.
The Short Course will focus on the two major USP chapters for measuring elemental impurities in pharmaceuticals, including Chapter <232> on Limits, and Chapter <233> on Analytical Procedures. It will give an historical perspective and timelines on how these new limits and procedures have been aligned with ICH (International Conference on Harmonization) Q3D Step 4 Guidelines, as well as covering the important topic of risk assessment, together with control strategies, and regulatory considerations. It will also discuss which plasma spectrochemical techniques are most appropriate to use and describe sample preparation approaches; calibration routines, maintenance procedures, troubleshooting tips and how best to meet the validation protocols that are an essential component of this new methodology.
Robert J. Thomas, CSci, CChem, FRSC
Robert Thomas has worked in the field of trace element analysis for over 40 year….24 years for a manufacturer of ICP-MS instrumentation, and 16 years as principal of his own consulting company. He has served on the American Chemical Society (ACS) Reagent Chemical Committee for the past 16 years where he has worked closely with the United States Pharmacopeia (USP) to align the testing procedures for elemental impurities in reagent chemicals with those of pharmaceutical materials. He has authored over 80 publications on trace element analysis and written four textbooks on the fundamental principles and real-world applications of ICP-MS. His most recent book is entitled “Measuring Elemental Impurities in Pharmaceuticals; A Practical Guide.” He has a graduate degree in Analytical Chemistry from the University of Wales in the UK and is a Fellow of the Royal Society of Chemistry (FRSC), and a Chartered Chemist (CChem).
Anthony J. DeStefano, PhD
Tony DeStefano obtained his BS in Chemistry from Villanova University and his MS and PhD degrees in Physical Chemistry from Cornell University. He was employed by Procter & Gamble for 31 years, most of them working in and managing pharmaceutical analytical and bioanalytical groups. In 2008 he joined the United States Pharmacopeia (USP) as its Vice President of General Chapters. At USP, he led the initiatives to maintain, update and redesign the General Chapters. He was a member of the ICH Q3D Expert Working Group on metal impurities. He is currently a consultant in analytical, compendial, bioanalytical and quality-related issues. He is a member of the American Chemical Society (ACS), Past-Chair of the Board of the Product Quality Research Institute (PQRI), and a past-president (2013) of the American Association of Pharmaceutical Scientists (AAPS).