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On November 28, 2011 the United States Pharmacopeial Convention (USP) published the first ten standards for the USP Medicines Compendium (MC). 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 a press release issued by the USP 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 access to the MC is free: www.usp-mc.org Source: Press Release USP
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