Who is USP
The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world’s top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP’s fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
Who are our Expert Volunteers?
A hallmark of USP’s standards is that they are determined by independent scientific experts, USP Expert Volunteers are selected based on their individual expertise and experience and use their best personal, professional, and scientific judgment to work collaboratively on setting standards, USP Expert Volunteers must agree to disclose conflicts of interest and to uphold standards of conduct that preserve the integrity of the standard setting process.
Focus Area
This Expert Panel will focus on development of a comprehensive new chapter (>1000) for the product quality and performance tests for LG-based microparticle dosage forms. This chapter specifically focuses on microparticle drug products currently on the market, formulated with biocompatible, bioabsorbable poly(lactide-co-glycolide) or poly(lactic acid-co-glycolic acid) polymer excipients (LG polymers). It will establish standardized guidelines and methodologies for the characterization, quality control, and application of microspheres in pharmaceutical formulations. By leveraging the expertise of leading scientists, researchers, and industry professionals, the panel will address current challenges and incorporate the latest advancements in microparticle technology. The resulting chapter will serve as a critical reference for regulatory compliance and innovation in drug delivery systems. Ultimately, this initiative seeks to enhance patient outcomes and support the development of high-quality pharmaceutical products. The panel responsible for creating this chapter and revising public comments from PF51(6) will also advise on the development of performance standards. This work will support USP's overall strategic goals by addressing current challenges faced by the pharmaceutical industry in quality and performance tests. By responding to stakeholder feedback, the panel aims to create an educational resource that will guide the successful implementation of LG polymer-based microparticle drug products in the pharmaceutical industry.
2025-2030 KEY ISSUES
This work will support USP's overall strategic goals by addressing:
- current challenges faced by the pharmaceutical industry in quality and performance tests.
- By responding to stakeholder feedback,
- the panel will aim to create an educational resource that will guide the successful implementation of LG polymer-based microparticle drug products in the pharmaceutical industry.
Member Responsibilities
- Explores specific compendial topic(s) and produces the deliverable(s) identified in the Expert Panel charge within a specific time frame
- Performs assigned tasks and provides recommendations to the sponsoring Expert Body/Bodies
- Provides final advisory recommendations in writing to the sponsoring Expert Body/Bodies
- Strives to reach agreement with other members on compendial topics, although achieving unanimous agreement is not required
- Participates in meetings (reads briefing materials, attends meetings, reviews minutes and notes, etc.)
- Notifies USP staff of conflicts of interest; keeps disclosures up to date
- A conflict of interest does not limit participation in discussions or the making of recommendations, provided the Expert Panel Member has disclosed this conflict. However, an Expert Committee Member who joins an Expert Panel is held to the move stringent conflict of interest requirements and Standards of Conduct applicable to an Expert Committee Member.
- Develops and maintains awareness of fellow volunteers’ conflict of interest to help facilitate conflict of interest management
- Disposes of any confidential materials at the conclusion of service
How will YOU create impact here at USP?
In this role as a USP Volunteer, you contribute to USP’s public health mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs.
Required Expertise
The successful volunteer candidate will have demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:
- Process development expert on Complex dosage forms
- Analytical Experts in Complex product characterization
- Quality by Design and life cycle management
- Manufacturing Science and Technology
- Real Time Release Testing
Additional Desired Preferences
- Technical writing
- Scientific research