Virtual Excipients Open Forum

Virtual Excipients Open Forum

Agenda Pre-read Material

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

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.

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 participated?

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

Pre-read Material

Open Forum Executive Summary

Q & A Summary – Unanswered Questions

Open Forum Presentations: Day One

  1. Overview of the Stakeholder Engagement Model (SEM) Tools, Jessica Simpson
  2. Goals and Objectives of the Excipient Open Forum, Catherine Sheehan
  3. Purpose of Stimuli Article. Overview of Guiding Principles and Approaches for Setting Specifications for Excipient Composition and Impurities, Galina Holloway and Richard Creekmore
  4. Review of Excipients Impurities Survey Responses, Galina Holloway
  5. Historical and Current Overview of USP-NF Excipient Monograph Composition and Impurity Revisions, Hong Wang
  6. Review of Pharmacopeial Discussion Group (PDG) Monographs with Impurity Revisions, Jenny Liu

Open Forum Presentations: Day Two

  1. USP Addressing Maltol PF 46(2) Comments, Peng Zhang
  2. USP Review of Stimuli Article’s Proposed Definitions relating to Excipient Composition, Galina Holloway
  3. Update on USP Element Specific Chapters, Kahkashan Zaidi
  4. Overview of First Draft of Roadmap for Addressing Element-specific Chapters and Tests in Excipients Monographs, Galina Holloway