Focus: 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. 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 non-traditional 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. Required Expertise: 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 Preferred Expertise: 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)