30. May 2018

18-19 September 2018 in Cologne - Germany OBJECTIVES Implementation of GMP in an excipient manufacturing site Qualification and auditing of suppliers Analytical data and certificates of analysis for excipients The European Pharmacopoeia’s General Methods Modernisation Programme USP – Strategies and Opportunities for Excipient Standard Setting Particulate matter in pharmaceutical starting materials and drug products Regulatory and technical challenges for excipients in parenteral...