ECA – Impurities Forum 2019

SGS’s will join the ECA’s Impurities Forum 2019 in Prague.

Background

Setting specifications for impurities is one of the most critical topics in the development of new drug products. Impurities analysis in drug substances and drug products and their recording and reporting is quite often a challenge for the scientific experts in routine production and quality control. This challenge is even bigger when profiles of unknown impurities in complex matrices have to be established. The recent Valsartan case made clear the importance of a thorough process understanding.

This event is designed to provide a comprehensive review of impurities analysis and characterisation in drug substances and drug products and their recording and reporting.

Part 1 of the Impurities Forum in Prague provides attendees with an opportunity to reinforce and expand their knowledge of the general area of impurities in chemical entities from initial development to the market with emphasis on:

• Detection, profiling and control of impurities in drug substances, intermediates and drug products
• Practical aspects of method validation for impurities Determination
• Analytical techniques used for detecting and qualifying impurities
• Extractables and leachables as a source of impurities
• “Unexpected Impurities” – lessons learned from the Valsartan case

In Part II of the Impurities Forum the key principles of the ICH Q3D Guideline will be highlighted. Attendees will get to know the essential aspects and approaches of determining and controlling elemental impurities in drug products.

For further information, please contact:

Josée Leach
Global Marketing Manager- Life Sciences
m: +44 (0)7889 939 512