Standardized Extraction Protocol Per USP <665>: Bridging Regulatory Expectations And Industry Best Practices

The increasing use of plastic-based single-use systems in pharmaceutical and biopharmaceutical manufacturing has intensified regulatory expectations around extractables and leachables (E&L). With USP <665> becoming mandatory in May 2026, manufacturers must adopt a standardized, risk-based approach to material characterization and qualification. This white paper explains how USP <665> and the companion chapter USP <1665> fit within the broader global regulatory landscape, including ICH Q3E, USP <1663>/<1664>, EU GMP, and BioPhorum guidelines. It outlines practical strategies for implementing standardized extraction protocols, performing quantitative correlations between extractables and leachables, and applying analytical evaluation thresholds to ensure patient safety. Through detailed methodology, regulatory perspectives, and step-by-step examples, the paper provides actionable guidance for qualifying single-use components, supporting regulatory submissions, and aligning industry best practices with evolving compendial requirements.