ROCKVILLE, Md., Nov. 29, 2011 /PRNewswire-Asia/ -- Offering a new vehicle for improving medicines quality around the world, the United States Pharmacopeial Convention (USP) last week published the first ten standards for the USP Medicines Compendium (MC) at www.usp-mc.org. The newly-authorized quality standards -- approved by USP's Council of Experts -- are for medicines used as anti-HIV agents, antivirals, analgesics, oral contraceptives and antiparasitic treatments.
The MC is a free, online source of public standards that help ensure the quality of chemical and biological medicines. As a scientific, nonprofit public health organization that develops standards for the quality of medicines, USP announced the creation of the MC in June of this year.
According to Roger L. Williams, M.D., chief executive officer of USP, "Approval of these initial MC standards is an example of USP's steadfast commitment to the improvement of global public health through quality standards for medicines. Intended for use by manufacturers, regulators, pharmacopeias and others worldwide, the MC provides rigorous quality assurance measures for medicines where they otherwise might not exist. It's through the availability of public standards such as those developed for the MC that manufacturers of a given medicine or ingredient can meet the same fundamental requirements, allowing practitioners to have confidence in the medicines they prescribe and patients in the medicines they take."
The MC includes monographs (written or "documentary" standards), general chapters (standards that apply to multiple monographs), and reference materials (highly purified physical samples of medicines used as reference chemicals for testing) for medicines and their ingredients, approved by national regulatory authorities and legally marketed in any country. The MC's innovative approach to creating public monographs with reference materials starts with a Performance Based Monograph (PBM) that gives tests for critical quality attributes and acceptance criteria, but does not give specific step-by-step procedures. By providing criteria for acceptable procedures, the information in a PBM allows USP to proceed with the development of a public monograph for inclusion in the MC, and for manufacturers to consider how they wish to develop their own acceptable procedures for either a private regulatory filing or the public monograph. Following completion of the PBM criteria, USP develops Reference Procedures that can be used to test any article under a monograph's title and are, thus, source-independent (i.e., not exclusively developed from a single manufacturer's procedures). Reference materials for these procedures are also provided to enhance testing capabilities. Once a source-independent Reference Procedure and any related reference materials are completed, a monograph standard is eligible for inclusion in the MC.
The recently authorized standards are for: acyclovir, acyclovir topical cream, amlexanox, chloroquine oral solution, chloroquine phosphate, chloroquine sulfate, etoricoxib, nelfinavir mesylate, ormeloxifene hydrochloride and stibogluconate sodium. Among the ten, the MC standard for the antiparasitic agent, stibogluconate sodium, is an example of a medicine for which no public drug quality standard has been available anywhere in the world until now. Approval of five more authorized standards is anticipated before the end of the year.
MC standards are created in an open, transparent process similar to that utilized for USP's other compendia. After a 90-day comment period during which a proposed standard is open to public review by any interested party, the standard proceeds to becoming authorized by a vote of an MC Expert Committee.
The first of USP's Expert Committees focused on the MC was established in the South Asia region, in India, a major exporter or medicines to the world. USP's Board of Trustees recently approved the formation of additional MC Expert Committees. The newest Expert Committee, to be composed of distinguished scientists from the Chinese community and whose initial focus will be on quality standards for excipients, is now forming in East Asia. Additional Expert Committees also may be formed in other regions for the development of standards for articles approved by regulatory authorities in those regions.
To learn more about the MC, please visit www.usp-mc.org or email mediarelations@usp.org.
USP -- Advancing Public Health Since 1820
The United States Pharmacopeial (USP) Convention is a scientific, nonprofit, standards-setting organization that advances public health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. USP's standards are recognized and used worldwide. For more information about USP visit http://www.usp.org.
CONTACT: Theresa Laranang-Mutlu
301/816-8167; trl@usp.org
