This webinar was recorded on 17-18 September 2020.
Part of the IPEC Europe Excipient Conference webinar series, organised in cooperation with APV GmbH.
DESCRIPTION
The IPEC Technically Unavoidable Particle Profile Guide gives guidance for the communication between excipient makers and users about visibly different particles in excipients. These types of particles have always been present in excipients and they are often known to the excipient manufacturer, have been previously investigated, and pose no risk to patient safety. With current technologies, these particles are technically unavoidable and cannot be eliminated in the finished excipient. This lecture will explain the risk-based approach of the guideline and give examples how information can be shared between excipient manufacturer and user.
