This webinar will provide excipient users (pharmaceutical companies, contract manufacturers, and other interested stakeholders) with practical advice and information necessary in order to conduct an elemental impurity risk assessment and ultimately assure compliance with the requirements of ICH Q3D. Discover how and where to source the necessary data and information from excipient and other suppliers, including the literature, internal test results and databases.
The presenter will also cite examples from his own experience with ICH Q3D, USP, and EP compliance and involvement with industry groups dealing with these issues.
Upon completion of this webinar, the participant should be able to:
- Describe the key ICH Q3D, USP and EP elemental impurity requirements as they apply to finished dosage forms
- Explain the process for performing a risk assessment to determine and justify permitted daily exposure (PDE) calculations for elemental impurity limits in finished dosage forms
- Identify several sources of published elemental impurity data and understand how such data may form part of an overall risk assessment
Andrew Teasdale, Ph.D, has over 20 years’ experience in the pharmaceutical industry as an analytical chemist and within quality assurance and regulatory roles. In his current role he chairs AstraZeneca’s Impurity Advisory Group. Dr Teasdale has published a number of papers relating to elemental impurities and other impurity related matters and has been a speaker at many international conferences. Dr Teasdale has also led a number of industry expert groups; these include both safety and quality groups within Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), Product Quality Research Institute (PQRI) and the Extractables and Leachables safety Information exchange (ELSIE). He also helped establish a cross industry group dedicated to the development of an elemental impurity database for excipients and is currently the leader of the IPEC EU ICH Q3D Implementation taskforce.