Presentation on Excipients

18 June 2018 - DC Fine Chemicals directors Josep Cortes and Juli Orihuela presented a seminar for a pharmaceutical group of companies. More than 60 people from 12 group companies attended the event. The subject of the presentation was risk management for Pharmaceutical Excipients. This comprised a brief overview of ICH Q9 “Quality Risk Management” and a more detailed review of the Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use (2015/C 95/02). Real examples from industry were included within the presentation. A copy of the guidelines can be downloaded by clicking this link.