Conclusion
Pharmacopeial public standards provide benefits to patients, practitioners, regulatory authorities, and industry. For patients
and practitioners, pharmacopeias promote consistency in medicines by establishing quality standards applicable to all drug
manufacturers. For regulatory agencies and industry, pharmacopeias provide a resource for methodology and guidance on non-GMP
topics. Pharmacopeias can facilitate drug registration and support regulatory agencies through appropriate standardization.
Globally aligned pharmacopeial standards can help ensure the quality and facilitate free movement of medicinal products worldwide.
Pharmacopeias clearly have a continuing role to play in assuring the availability of quality pharmaceuticals to meet the demands
of today's global healthcare environment. Moving toward an ideal pharmacopeia would further enhance their role in supporting
and promoting global public health through safe and effective medicines of appropriate quality for patients throughout the
world.
J. Mark Wiggins* is a principal scientist in Regulatory and Analytical Sciences–Compendial Affairs at Merck & Co., 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
. Janeen A. Skutnik is director of Quality & Regulatory Policy–Global Regulatory CMC at Pfizer. Judy L. Shimek-Cox is recently retired from her position as a principal regulatory scientist at Eli Lilly and Company, and Neil A. Schwarzwalder is a global compendial consultant for the Global Quality Laboratories at Eli Lilly and Company. All authors are current or
former representatives on the Compendial Liaison Team at the Pharmaceutical Research and Manufacturers of America (PhRMA).
*To whom all correspondence should be addressed.
References
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Compendia" (MAPP 5310.7), Nov. 3, 2007, available at.
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