Dr. David Schoneker

Elemental Impurities – Current Status of ICH and USP <232> & <233> – Implementation Challenges –  Impurezas elementales – Estado actual de la ICH y USP <232> & <233> – Desafíos de la Implementación.


David R. Schoneker is the Director of Global Regulatory Affairs at Colorcon. His responsibilities include global coordination of Colorcon’s worldwide regulatory activities and raw material assessments.

He received his B.S. degree from Ursinus College and M.S. in Chemistry from Villanova University. His previous position at Colorcon was Director of Quality Assurance and Quality Control. He has been at Colorcon since 1977. Mr. Schoneker has been active in many professional organizations such as AAPS, PQRI, RAPS, ASQ, ACS, AOAC and the Delaware Valley Chromatography Forum. He also is involved with a number of trade organizations such as the International Pharmaceutical Excipients Council (IPEC), the International Association of Color Manufacturers (IACM), the International Food Additives Council (IFAC), the Council for Responsible Nutrition (CRN), the Consumer Health Products Association (CHPA) and the Institute of Food Technologists (IFT).

Mr. Schoneker was the Chairman of IPEC Americas during the period 2007-2009. He is now serving as the Vice Chair of Maker and Distributor Relations where he is actively involved with the development of Excipient GMP and Supplier Qualification related guidelines to improve Global Supply Chain Security. He also Co-Chairs IPEC’s QbD/Product Development Committee and Composition Committee and is a member of the Board of Directors of the IPEC Foundation.

He has acted as an interface with many international regulatory agencies and pharmacopeias for the organization. He has served as the USP Liaison for IPEC Americas in the past and is still actively involved in various activities of the United States Pharmacopeia Convention. Mr.

Schoneker previously coordinated all International Harmonization efforts for the group and participated in the development of IPEC’s Good Manufacturing Practices Guide and Auditing Guide for Bulk Pharmaceutical Excipients. He has also led IPEC’s efforts in developing guidelines for excipient qualification, significant change notification and the appropriate use of certificates of analysis. Additionally, Mr. Schoneker chairs a number of harmonization working groups on various excipients.

Mr. Schoneker has participated in the area of Color Science for many years and is author of the chapter “Coloring Agents for Use in Pharmaceuticals” in the 2nd edition of the Encyclopedia of Pharmaceutical Technology which was published in 2002He has also authored a number of other excipient quality and safety related papers in various journals and trade magazines.

Mr. Schoneker has also been actively involved in developing various Anti-Counterfeiting Authentication technologies which utilize unique excipient, taggant and colorant solutions for overt and covert on-product authentication.


ICH and USP have developed guidelines (Q3D) and general chapters <232>/<233> related to Elemental Impurities in drug products. The ICH Q3D Expert Working Group (EWG) published the Step 4 version of the Q3D Guideline in December 2014.  The ICH Q3D and USP <232> requirements became oficial in June 2016 for new drug products and will become official in the U.S. and Europe by January 2018 for existing drug products.

Finished drug product manufacturers will need to develop their own plans for doing appropriate risk assessments of their drug products and analytical testing, where needed, to determine whether they will meet the Q3D PDE requirements and what control strategies may be needed to insure ongoing compliance.

This presentation will provide an update on the current status of the ICH and USP Elemental Impurity initiatives, discuss the challenges related to many common excipients and analytical test methodologies and outline risk assessment concepts that can be used by pharmaceutical companies who will need to comply with these requirements in the future. Various implementation and analytical challenges still occur which may creat some problems for industry once these requirements move into the compliance mode.  Industry efforts to work with regulators and pharmacopeias for a rational implementation will be outlined.