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 the comprehensive review and strategic revision of USP <790> and <1790> to modernize and strengthen standards for visible particulate matter and visual inspection. The Panel will address emerging product modalities, silicone oil and packaging-related particles, statistical sampling and trending approaches, and alignment between visible and subvisible particle strategies. The work will ensure practical, risk-based, and scientifically grounded updates as part of the 2025–2030 revision cycle. 2025-2030 KEY ISSUES • 100% vs. sampling: Clarify the distinction between 100% inspection and acceptance or supplemental sampling at release and in distribution. • Statistical sampling and trending: Strengthen clarity around statistical process sampling, PPQ sampling, threshold testing, AQL application, and trending approaches to ensure consistent implementation. • Inspection conditions: Clarify that <790> inspection parameters cited in <1790> are context-specific and not universally mandatory. • Difficult-to-inspect products: Provide clearer guidance for opaque, viscous, low-fill, or nontraditional container systems. • Emerging product modalities: Ensure expectations address cell and gene therapies, viral vectors, lipid nanoparticles, and other novel injectables. • Device and packaging-related particles: Clarify the role of delivery devices, container-closure systems, and packaging components as particle sources. • Silicone oil: Provide clearer guidance on silicone oil droplets, their sources, characterization, and risk context. • Particle terminology: Strengthen clarity around intrinsic, extrinsic, inherent, and process-related classifications. • Inspector qualification: Ensure training and performance expectations reflect current practice without being prescriptive. • Automated technologies: Clarify the role of automated and emerging inspection systems relative to human inspection. • ·Visible–subvisible alignment: Improve alignment between <790>, <1790>, <788>, and related chapters to support a coherent visible and subvisible particle strategy, including sub-10 µm considerations. 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: USP seeks experts in visual inspection and visible particulate matter control for injectable and ophthalmic products. Relevant expertise includes manual and automated inspection technologies, statistical sampling and trending (including AQL and PPQ), particle characterization, silicone oil and packaging-related particles, and alignment of visible and subvisible strategies. Experience with emerging modalities (e.g., cell and gene therapy, viral vectors, lipid nanoparticles) and global regulatory expectations is desirable Additional Desired Preferences The expert volunteer should have experience in one or more of the following areas for one or more of these modalities: • Visual Inspection Science & Methodology (manual and automated inspection systems) • Visible Particulate Matter Characterization (intrinsic, extrinsic, inherent, and process-related defects) • Statistical Sampling & Quality Systems (AQL, acceptance sampling, PPQ, threshold testing, trending) • Risk Assessment & Toxicology (patient risk evaluation and defect impact assessment) • Particle Identification Techniques (microscopy, spectroscopy, forensic characterization methods) • Manufacturing & Quality Control (GMP inspection programs, lifecycle management, defect libraries) • Single-Use, Packaging & Device-Related Particle Sources (CCS, syringes, cartridges, delivery systems, silicone oil) • Emerging Modalities (Cell & Gene Therapy, viral vectors, lipid nanoparticles, complex injectables) • Visible–Subvisible Alignment (<790>, <1790>, <788> integration strategies) • Difficult-to-Inspect Products (opaque containers, viscous/colored fills, low fill volumes) • Global Regulatory Expertise (FDA, EMA, EU Annex 1, international standards)