USP Open Forum | Excipients

The United States Pharmacopeial Convention (USP) will be hosting a virtual Excipients Open Forum on Thursday, February 11, 2021, and Friday, February 12, 2021, 9:00 a.m. – Noon (ET) on the topic “Setting Compendial Specifications for Excipient Composition, Organic and Inorganic Impurities.”

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PRE-READS

SURVEYS

Open forums

USP open forums are a platform to discuss and receive inputs from a broad range of stakeholders on a key topic, to better understand the impact on industry and regulators. The forum enables USP to understand the landscape and inform on the advisability of an issue.

The Excipients Open Forum will provide an opportunity for manufacturers, distributors, users of excipients, and regulatory agencies to meet in an open setting. USP hopes the Forum will encourage excipients constituencies to work openly and directly with USP and collaborate with fellow stakeholders.

The Excipients Open Forum will also be a venue for USP staff to inform USP Excipient stakeholders of USP’s Standards Engagement Model, work in progress, and opportunities to support the development of new standards.

To maximize the effectiveness of the discussion on February 11 and 12, and continuously improve our engagement, we have three surveys. The first couple of surveys are on the main topics, “Complexities in setting compendial specifications for excipient composition and impurities (organic impurities)” and “draft roadmap for addressing element specific chapters and tests in excipient monographs”,  and are to be completed upon registration. We request you to read the agenda prior to completing the first two surveys. The third survey is a general poll to collect feedback to improve our stakeholder engagement further. Please click on Stakeholder Engagement link to complete the third survey. Please complete the surveys by January 31, 2021.

Registration is free; it is also required. You can register using this registration link. The surveys will also be available on our registration site. For further information or to suggest additional stakeholder topics, please contact Jacqueline D. Starkes.

Key objectives

  • Discuss the Complexities of Setting Specifications for Excipients Composition and Impurities Organic Impurities
  • Discuss the Excipients Elemental Impurities Draft Roadmap
  • Report out and discuss the results of the surveys
  • Educating stakeholders on USP activities while helping USP staff understand excipients issues
  • Providing information on emerging USP initiatives that might affect excipients stakeholders

Who should participate?

  • Excipients makers
  • Pharmaceutical manufacturers
  • Contract manufacturers
  • Formulators/drug developers
  • Contract research organizations
  • Regulatory agencies
  • Distributors
  • Suppliers service providers
  • Academia

Pre-read Material