On December 19, 2014, the Guideline "ICH Q3D - Elemental Impurities" was issued by the ICH, providing a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients. The required comprehensive view on a products’ elemental impurities from all sides will cause major challenges for the pharmaceutical and chemical industry. In this webinar Dr. Dorothee Kriha will provide a close look at the core elements of the Guideline, outline challenges and give insight into what BASF as pharmaceutical ingredient supplier has done to help customers to comply with the new requirements for elemental impurities right from the start.
Dr Dorothee Kriha
Regulatory Affairs Manager
Platform Marketing Pharma Ingredients