● developing acceptable levels for other routes of administration
● justification for exceeding a Permitted Daily Exposure (PDE)
● developing acceptable levels for elemental impurities not covered by ICH Q3D
● considerations for large volume parenterals
● general approaches to risk assessment
● controls on elemental impurities
● calculations between PDE values and concentration limits.
Two additional modules are in progress, and will cover risk assessment examples and FAQs.