Atypical Visible Particles: Can Users and Makers Find Common Ground?

In April 2012, industry experts discussed the issue of atypical visible particles in pharmaceutical raw materials, including excipients, at the joint International Pharmaceutical Excipient Council’s (IPEC) Regulatory Conference and ExcipientFest-Americas Conference in San Juan, Puerto Rico. This topic is key because a primary cause of drug recalls during the past year has been the presence of visible particles, that is off-colored particles or black or tan specs, in pharmaceutical products. The presence of visible particles affects both excipients manufacturers and users with regard to standard expectations for mitigating the atypical visible particles and with regard to decision-making about raw material acceptance criteria.

The International Pharmaceutical Excipients Council (IPEC) is working to develop and fast-track a guideline on how to measure and properly assess the significance of these visible particles, particularly within white polymer powders. The guideline is meant to dispel any confusion around the presence of particles in excipients and to provide information for excipients users and makers on how to proceed when making decisions about these particles. On the April 2012 panel were Dr. Lucinda Buhse, director of the Division of Pharmaceutical Analysis in FDA’s Office of Pharmaceutical Science at CDER; Ann Van Meter, chair of the IPEC GMP Committee and of the IPEC Atypical Visible Particles Working Group; Dave Schoneker, director of Global Regulatory Affairs at Colorcon and past IPEC–Americas Chairman; and Dale Carter, current chair of IPEC–Americas. The audio file of this roundtable is now available to listen to at PharmTech.com/ExcipientFest. The full transcript can also be read.

Coming up in September, Pharmaceutical Techology is hosting a free educational webinar on this very topic to further discuss the issues at stake.