2025-2030 Focus: This Expert Panel will focus on the comprehensive review and revision of USP General Chapter <665> Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products and its associated informational chapter <1665>. The Panel will modernize the chapters to reflect advances in single-use systems, material science, and analytical capabilities; address stakeholder feedback; and align the standards with evolving global regulatory expectations, including the developing ICH Q3E guideline on extractables and leachables. 2025-2030 Issues: • ICH Alignment and E&L Integration: Assess how <665> and <1665> fit within the broader extractables and leachables framework, including alignment with current and emerging ICH initiatives. • Scope Boundaries: Clarify scope distinctions (e.g., plastics vs. elastomers, filters, silicone edge cases) and references to related chapters such as <381> and <382>. • Risk-Based Framework: Ensure the risk-based approach is clearly articulated, including flexibility for low-risk components. • - Legacy Expectations and Audience: Confirm that expectations for legacy components and the intended audience are clearly defined. • Solvent Language: Review extraction solvent language to address recurring stakeholder questions. • Extractables vs. Leachables: Strengthen distinction between extractables requirements and leachables considerations to avoid unintended interpretation. Required Expertise: USP seeks experts with experience in plastic components and single-use systems used in pharmaceutical and biopharmaceutical manufacturing. Relevant expertise includes extractables and leachables (E&L) science, polymer and materials characterization, toxicological risk assessment, and risk-based evaluation of manufacturing components. Candidates should have practical knowledge of GMP manufacturing, supplier qualification, lifecycle management, and global regulatory expectations, including familiarity with emerging frameworks such as ICH Q3E. Experts from industry, analytical laboratories, toxicology, and regulatory backgrounds are encouraged to participate. Preferred Expertise: • Single-Use Systems (SUS) and Disposable Technologies • Design, qualification, and lifecycle management of single-use systems - Polymer processing and fabrication • Supplier technical leadership - Extractables and Leachables (E&L) Science Study design and protocol development • Advanced analytical characterization (GC-MS, LC-MS, ICP-MS, TOC, etc.) - Data interpretation and reporting frameworks