The Risk Assessment Approach

This chapter provides the concept of a risk assessment approach as required for regulatory submissions of drug products. International Conference on Harmonization (ICH) Q3D recommends that manufacturers conduct a product risk assessment by first identifying known and potential sources of elemental impurities. The structured scientific-based and data-driven risk assessment ensures that the control strategy is appropriate and does not impact the product quality or patient safety. ICH Q3D explains that "elemental impurities are often associated with mined materials and excipients. The presence of these impurities can be variable, especially with respect to mined excipients, which can complicate the risk assessment. The risk of inclusion of elemental impurities can be reduced through process understanding, equipment selection, equipment qualification, and good manufacturing practices processes. The specific elemental impurities of concern should be assessed based on knowledge of the composition of the components of the manufacturing equipment.