United States Pharmacopoeial Convention (USP) had recently published the First Ten Quality Standards in New Medicines Compendium (MC) for medicines used as anti-HIV agents, antivirals, analgesics, oral contraceptives and anti-parasitic treatments. The newly-authorized quality standards have been approved by USP’s Council of Experts.
The newly published quality standards will now offer a new vehicle for improving medicines quality around the world. The MC is a free, online source of public standards that help ensure the quality of chemical and biological medicines.
Roger L Williams, MD, chief executive officer of USP, said, “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, pharmacopoeias 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 that are source independent.
Some of the medicines which have been included in authorized standards include, 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 anti-parasitic 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.