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.
- 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
Ann Van Meter recently retired as Business Quality Leader and GMP Subject Matter Expert for Dow Pharma and Food Solutions. She was employed by the Dow Chemical Company for 25 years. A chemical engineer by training, Ann has held a variety of EHS and Quality Roles throughout her career. Prior to her retirement, Ann was actively engaged as the Dow representative in the International Pharmaceutical Excipients Council. She also served as chair of the GMP Committee and as a member of the Executive Committee. She led the Validation Task Team and the Technically Unavoidable Particles Work Group.