The Ideal Pharmacopeia - Pharmaceutical Technology

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The Ideal Pharmacopeia


Pharmaceutical Technology
Volume 32, Issue 11, pp. 122-125

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,
. 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

1. WHO, "Index of Pharmacopoeias" (2006), available at http://www.who.int/medicines/publications/pharmacopoeia/HOPSMQSM2006_2_IndexPharmacopoeiasUpdated.pdf, accessed Sept. 25, 2008.

2. USP, US Pharmacopeia 31–National Formulary 26, p. v (2008)

3. JP, Japanese Pharmacopoeia 15, p. i (2006).

4. Ph. Eur., European Pharmacopoeia 6.0, p. v (2008).

5. Committee for Medicinal Products for Human Use, "Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials," EMEA, London, Mar. 31, 2006, available at http://www.emea.europa.eu/pdfs/human/qwp/18540104en.pdf, accessed Sept. 25, 2008.

6. FDA Center for Drug Evaluation and Research, "Manual of Policies and Procedures: Acceptability of Standards from Alternative Compendia" (MAPP 5310.7), Nov. 3, 2007, available at. http://www.fda.gov/cder/mapp/5310.7R.pdf.

7. EMEA/FDA, "Transatlantic Cooperation in Pharmaceutical Regulation: Identifying Opportunities for Admnistration Simplification," Nov. 28, 2007, available at http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2007/2007_11/tasw_joint_announcement.pdf, accessed Sept. 25, 2008.


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