At least half of excipient manufacturers, distributors and drug-product manufacturers test some, most, or all of their excipients
by alternate international (Ph.Eur., JP) compendial methods instead of USP–NF (see Figure 8).
Appendix: Excipient Working Group Recommendations for a PQRI Workshop
Nearly 60% of excipient and drug-product manufacturers conduct excipient testing per harmonized monographs, and reduce redundant
testing by either demonstrating multiple compendial specification equivalence or using the most stringent method or specification
for confirming compliance with more than one compendium. Approximately 50% of both excipient manufacturers and drug-product
manufacturers have applied harmonized excipient monographs and harmonized general chapters across all their sites (see Figure
The PQRI and its Excipient Working Group encourage active participation by stakeholders from excipient manufacturers,
excipient distributors, drug-product manufacturers, compendia, and regulatory agencies in discussing the current issues and
for developing possible solutions to problems faced by pharmaceutical excipient manufacturers, distributors, and drug-product
1. European Agency for the Evaluation of Medicinal Product (EMEA), Note for Guidance on Excipients, Antioxidants and Antimicrobial Preservatives in the Dossier for Application for Marketing
Authorisation of a Medicinal Product (CPMP/QWP/419/03) (EMEA, London, UK, Feb. 20, 2003).
2. US Food and Drug Administration, Guidance for Industry, Drug Product: Chemistry, Manufacturing, and Controls Information (FDA, Rockville, MD, Jan. 2003), now withdrawn, Fed. Reg. 71 (105), 31194–31195 (June 1, 2006).
3. United States Pharmacopeia 29–National Formulary 4, General Notices, section Tests and Assays under Procedures (United States Pharmacopeia Convention, Rockville, MD, 2006).
4. FDA, "Guidance for Industry on Chemistry, Manufacturing, and Controls Information; Withdrawal and Revision of Seven Guidances,"
Fed. Reg. 71 (105), 31194–31195 (June 1, 2006).
5. Details are posted online at http://
6. Product Quality Research Institute (PQRI) workshop on Excipient Testing and Control Strategies, Oct. 10–11, 2006, Marriott
Bethesda North Conference Center in Maryland.
The authors are members of the Pharmaceutical Quality Research Institute's Excipient Working Group.
Gregory Larner is a statistics manager with Pfizer Scientific and Laboratory Services (Kalamazoo, MI). David Schoneker is the chair-elect of the International Pharmaceutical Excipients Council of the Americas, (IPEC-Americas) and the director
of global regulatory affairs at Colorcon (West Point, PA). Catherine Sheehan is the director for the excipients group at the United States Pharmacopeia (Rockville, MD). Rajendra Uppoor, RPh, PhD, is
a pharmacist in the Office of Pharmaceutical Science, Center for Drug Evaluation and Research, US Food and Drug Administration
(Silver Spring, MD). Phyllis Walsh is a senior compendial manager at Schering-Plough Corporation (Kenilworth, NJ). Robert Wiens* is a senior quality representative at Eli Lilly and Company, Compendial Affairs/Global Method Management, Drop Code 2638,
Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN 46285, tel. 317.276.4861, email@example.com
*To whom all correspondence should be addressed.
The views expressed in this article are the authors' own, and are not necessarily those of Colorcon, Eli Lilly, Pfizer, Schering-Plough,
the US Food and Drug Administration, or the US Pharmacopeia.
Submitted: June 26, 2006. Accepted: July. 24, 2006.
Keywords: excipients, manufacturing, testing