Conclusion
The goal of achieving globally harmonized compendial standards has been approached in several ways with limited success. The
new approach for compendial globalization described here is intended to increase the pace of harmonization, and help promote
global public health. The three principles of standardized pharmacopeial practices, pharmacopeial collaboration, and regulatory
acceptance are relatively simple, but require new ways of thinking and working. With commitment by impacted stakeholders,
the benefits of compendial globalization should extend to the pharmacopeias, regulators, industry, and ultimately, patients
worldwide.
Acknowledgment
The authors are grateful to Janeen Skutnik-Wilkinson, Pfizer, Quality & Regulatory Policy, for helpful discussions during
the initial development of this article.
J. Mark Wiggins* and Howard D. Schneider, Jr., are in Global CMC Regulatory Affairs, Quality Standards–Compendial Affairs, at Merck, WP82-10, 770 Sumneytown Pike, P.O.
Box 4, West Point, PA, 19486-0004, tel. 215.652.3964, fax 215.652.0834, mark_wiggins@merck.com
.
To whom all correspondence should be addressed.
References
1. J.M. Wiggins, J.A.Skutnik, J.L. Shimek-Cox, and N.A. Schwarzwalder, Pharm. Technol.
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2. ICH, Q4B Guideline and Annexes: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.
3. J.M. Wiggins, P.M. Travis, A. Park, and R.A. Fitzgerald, "Ph. Eur/USP Prospective Harmonization—API Pilot Project: Industry Perspective," Pharmeuropa, 22 (4) 415–418 (October 2010); Pharmacopeial Forum 36 (6) 1792–1796 (November–December 2010); Japanese Pharmacopoeial Forum 20 (1) 49–53 (March 2011).
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