On-demand: The 7 truths of impurities - the FDA and other regulators' viewpoints and further stories (part 1)
Presenter: Dr Christian Zeine, Global Product Manager Pharmaceuticals, LGC Standards
Released: 25 July 2013
You couldn't make this webinar? Watch the presentation on-demand!
Impurities continue to be a hot topic in pharmaceutical development. Their presence or absence helps to drive a number of decisions, including the route to synthesis, the choice of suppliers for drug substances, and a number of other issues that depend on the impurity profile of the given product. ICH, FDA and other regulatory bodies issue guidance on how to detect, report, identify and qualify impurities, and the work of analytical departments (Analytical R&D, Method Validation and Quality Control) is essential in order to comply with the rules.
This webinar builds on the vast experience LGC Standards has with impurities and the regulatory background. The experience is summarised in seven statements, representing the '7 truths of impurities and their reference standards'.