Joint Position Paper on Pharmaceutical Excipient Testing and Control Strategies - Pharmaceutical Technology

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Joint Position Paper on Pharmaceutical Excipient Testing and Control Strategies
This article presents collaborative positions among excipient manufacturers, drug product manufacturers, and members of the US Pharmacopeia on key issues pertaining to the control of pharmaceutical excipients stemming from a recent Pharmaceutical Quality Research Institute workshop.


Pharmaceutical Technology


The authors are members of the Pharmaceutical Quality Research Institute's Excipient Working Group. Brian Carlin is global manager of pharmaceutical research and development at FMC-Biopolymer (Princeton, NJ). Dale Carter is manager of product quality and management systems, Office of Compliance and Ethics, at Archer Daniels Midland Company (Decatur, IL). Moira Griffiths is director of quality operations at Pfizer (Groton, CT). Gregory Larner is statistics manager at Pfizer Scientific and Laboratory Services (Kalamazoo, MI). Kevin Moore, PhD, is a scientist, Excipients, at United States Pharmacopeia, (Rockville, MD). Barry Rothman is a senior compliance officer, at Center for Drug Evaluation and Research, US Food and Drug Administration (Rockville, MD). David Schoneker is chair of the International Pharmaceutical Excipients Council of the Americas, (IPEC-Americas) and director of global regulatory affairs at Colorcon (West Point, PA). Catherine Sheehan is director, Excipients and Food Chemical Codex at the United States Pharmacopeia. Rajendra Uppoor, RPh, PhD, is a pharmacist in the Office of Pharmaceutical Science, at Center for Drug Evaluation and Research, US Food and Drug Administration (Silver Spring, MD). Phyllis Walsh* is senior compendial manager at Schering-Plough Corporation (Kenilworth, NJ),
Robert Wiens* is senior quality representative at Eli Lilly and Company (Indianapolis, IN)

*To whom all correspondence should be addressed. The views expressed in this article are the authors' own and are not necessarily those of Archer Daniels Midland Company, Colorcon, Eli Lilly, FMC-Biopolymer, Pfizer, Schering-Plough, the US Food and Drug Administration, or the US Pharmacopeia.

Submitted: June 21, 2007. Accepted: July 18, 2007.

References

1. G. Larner et al., "PQRI Survey of Pharmaceutical Excipient Testing and Control Strategies Used by Excipient Manufacturers, Excipient Distributors, and Drug-Product Manufacturers," Pharm. Technol. 30 (9), 90–98 (2006).

2. 21 CFR Regulations can be accessed at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm (type Part and Section # in search, e.g. 211.84).

3. FDA, Guidance for Industry: PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, http://www.fda.gov/cder/guidance/6419fnl.htm.

4. Federal Food, Drug, and Cosmetic Act, http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm.

5. FDA, Guidance for Industry—Testing of Glycerin for Diethylene Glycol, http://www.fda.gov/cder/guidance/7654fnl.htm.

6. ICH Q6A, section 2.1, http://www.ich.org/cache/compo/276-254-1.html.

7. Good Trade and Distribution Practices for Pharmaceutical Starting Materials, World Health Organization, WHO Technical Report Series, No. 917, 2003.


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