Inside IPEC: IPEC Tackles Monographs, Impurities, Particles, and More - Pharmaceutical Technology

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Inside IPEC: IPEC Tackles Monographs, Impurities, Particles, and More
As the excipient supply chain becomes more complex, industry must up the ante to comply with new standards and regulations.

Pharmaceutical Technology
pp. 49-50


A relatively new area of the federation's work is an attempt to monitor nanotechnology developments with respect to their impact on excipient monographs, as well as in the context of draft guidance on nanotechnology published by FDA in June 2011 (1). A major concern for the excipient industry is that excipients not developed for their "nano" properties may fall within particle-size range definitions being discussed for "nano" materials and therefore may be required to comply with potential new safety-assessment requirements.

Particularly, the federation is looking to change the particle-size range expansion from less than 100 nm to a range of 100 nm to 1 g. There is a need for global harmonization of these initiatives within US, Europe, and other countries. IPEC has worked with various trade associations to submit comments regarding these issues to FDA in response to their draft guidance.

Overall, the federation's 2011 work plan is full, but much remains to be done. Many of the initiatives mentioned here will continue into 2012, as will the organization's member-expansion program.


The author would like to thank David S. Schoneker with IPEC–Americas for his contribution to this article.

Patricia Rafidison is chair of the IPEC Federation, and the global regulatory affairs and compliance manager at Dow Corning.


1. FDA, Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology (FDA, Rockville, MD, June 2011).


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