Excipient regulations, guides, position papers, white papers – here’s how it all fits together! Total Excipient Control (TEC) is the culmination of three decades of IPEC efforts - a "systems approach" to excipient design, safety, manufacturing, and distribution.
Excipient regulations, guides, position papers, white papers – here’s how it all fits together! Utilizing all existing IPEC guidelines, programs and proposals to build an overall quality control system, including:
- Excipient Design Controls: how design criteria are set to meet the requirements for the intended use taking Quality by Design into account.
- Excipient Safety: information that has been developed to support the safe use of the excipient in the intended application at the levels of use expected to be experienced by the patient.
- Excipient Manufacturing Process Control and Distribution: the area of control traditionally covered by GMPs, Auditing, QC testing, Information Sharing and Supply Chain Security.
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. He has been at Colorcon since 1977. Mr. Schoneker was the Chairman of IPEC Americas during the period 2007-2009. He is now serving as the Vice Chair of Science and Regulatory Policy. He is also a member of the Executive Committee of IPEC-Americas, and on the Board of Directors of the IPEC Foundation.
Dave serves as the Global Expansion Coordinator for the IPEC Federation and has been involved in the start-up of various other IPEC groups such as IPEC China and IPEC India.