Compendial Globalization: Achieving Harmonization through Standardized Practices and Collaboration - Pharmaceutical Technology

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Compendial Globalization: Achieving Harmonization through Standardized Practices and Collaboration
The authors discuss a new approach to address globally harmonized compendial standards.


Pharmaceutical Technology
Volume 36, Issue 4, pp. 94-101

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,
.

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. 32 (11) 122–125 (2008).

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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