USP Update on excipient standard setting activities – the importance of stakeholder engagement with USP - Presentation @ ExcipientFest Americas 2017

ABSTRACT: The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that publishes monograph standards for identification and testing of drug products, excipients, foods and dietary supplements, among other related products.  USP’s monographs and over 3500 reference standards are used in more than 140 countries for regulatory and industry quality control.  Supported by FDA and by public and industry outreach efforts, the USP monograph Up-to-Date initiative continues to improve the relevance and quality of excipient standards to help qualify excipients for their intended use and assure the quality of pharmaceutical products, in furtherance of USP’s stated mission of improving global public health.  USP welcomes participation and contribution - including revisions to monographs, donation of bulk material to be developed into reference standards, and shared expertise - from interested parties in our collaborative standards-setting activities.  This presentation provides examples of recent collaborative efforts for excipient revision proposals published in the Pharmacopeial Forum (PF).

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