Recording from Wednesday, September 12, 2018

Low levels of visible particles can result from the excipient manufacturing, handling, or packaging processes, which do not look like the rest of the batch but pose no risk to formulation or patient safety. The appearance of the particles has caused users to reject batches of excipient upon visual inspection due to a lack of understanding of their nature.

Ann Van Meter, former Business Quality Leader and GMP Subject Matter Expert for Dow Pharma and Food Solutions, will address the significance of TUPs for makers, users and distributors. She will present the TUPPs Guide and discuss its role for all stakeholders.

Learning Objective
> The origin of TUPs in excipients
> Understanding the nature and significance of TUPs
> Facts and myths regarding TUPs
> Understanding the role of IPEC’s new TUPP Guide in supporting a risk-based approach for evaluating visible particles in excipients