The International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) is spearheading an effort to strengthen the communication pathway between excipient makers and users about the significance of benign visible particles in excipients.
In focus are low levels of visible particles that 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.
In response to the communication challenges, IPEC-Americas has developed a “Technically Unavoidable Particle Profile” (TUPP) guide, which is nearing clearance internally and by IPEC Europe.
IPEC-Americas held a webinar in late October to review the issues surrounding technically unavoidable particles (TUPs) and the role the new guide will play in helping excipient manufacturers and users address them. The webinar was led by Dow Pharma Business Quality Leader and GMP Subject Matter Expert Ann Van Meter, who served as the leader of the IPEC-Americas TUPP working group.