This module will address in detail how to control impurities in active substances in the context of a CEP application. The presentation will outline how to build and justify an appropriate control strategy, not only for organic and mutagenic impurities but also for elemental impurities and organic solvents. Concepts will be illustrated with concrete examples and applicable regulatory requirements will be described.
The presentation will be followed by a live Q&A session.
Programme (subject to change):
10:00-11:00 Control of impurities: CEP approach
11:00-11:30 Live Q&A session