Challenges to conclude elemental impurities risk assessment for pharmaceutical dosage form and submission in regulatory dossier

Abstract

ICH Q3D defines a science and risk-based assessment process to identify, evaluate, and define controls to limit elemental impurities in drug products. The present article comprise challenges and simplified approach to draw elemental impurities risk assessment and control in final drug product to satisfy current regulatory requirements using different calculation options. Detail risk assessment depends on information/knowledge of most significant potential sources of elemental impurities, i.e. drug product components, manufacturing process of drug substance or drug product, container closer system, etc. If there is lack of information available, the applicant may carry out end product testing as the initial strategy for risk assessment using option 3 calculation.