By following the measures described in this article, the excipient supply chain can continue to provide excipients that are
suitable for use in pharmaceuticals.
Irwin Silverstein*, PhD, is vice-president and chief operating officer, and Arthur Falk, PhD, is president and CEO, both at International Pharmaceutical Excipients Auditing,1655 N. Fort Myer Drive, Suite 700, Arlington,
VA 22209, tel. 703.351.5266, Irwin.email@example.com
. Dale Carter, MS, is global director of quality of J.M. Huber's silica business unit. Maria Guazzaroni Jacobs, PhD, is director of quality and regulatory policy for worldwide pharmaceutical sciences at Pfizer. David Schoneker is director of global regulatory affairs at Colorcon, chairman of the International Pharmaceutical Excipients Council of
the Americas (IPEC–Americas), and a member of Pharmaceutical Technology's Editorial Advisory Board.
*To whom all correspondence should be addressed.
1. Code of Federal Regulations, Title 21 Food and Drugs (US Government Printing Office, Washington, DC) Part 110, pp. 216–226.
2. IPEC, "White Paper on Excipient Pedigree," manuscript in progress as of Sept. 3, 2008.
3. IPEC–Americas, Standardized Excipient Information Protocol User Guide (Arlington, VA, 2005).
4. D. Klug, A. Van Meter, and Laura Horne, "The Excipient Information Package, A Win–Win Solution," Pharm. Technol.
31 (11), 121–122 (2007).
5. USP 31–NF 26 General Chapter <1078>, "Good Manufacturing Practices for Excipients."
6. IPEC, The Joint IPEC–PQG Good Manufacturing Practices Guide for Bulk Excipients (2006).
7. IPEC, The Joint IPEC–PQG Good Manufacturing Practices Audit Guide for Pharmaceutical Excipients (2007).
8. IPEC, The IPEC Good Distribution Practices Guide for Pharmaceutical Excipients (2006).
9. IPEC, The IPEC Good Distribution Practices Guide for Pharmaceutical Excipients (2008).