USP General Chapter <665>: Separating Fact from Fiction - Seguridad Mania.com - España y América Latina

This presentation summarizes USP General Chapter <665>, which provides guidelines for qualifying plastic components and systems in pharmaceutical and biopharmaceutical manufacturing. It introduces a risk-based framework, starting with an initial suitability assessment and a matrix that classifies components as low, moderate, or high risk. Testing requirements—such as extraction solvents, temperature (40 °C), and duration—are tailored to each risk level to ensure science-driven practices. The scope covers all drug products and biopharmaceuticals, excluding APIs for traditional small molecules and certain auxiliary items. The chapter emphasizes dynamic extraction conditions and standardized surface-area-to-solution ratios for consistency. While <665> is currently informational, it may become enforceable if referenced in USP notices or monographs. Alternative, scientifically justified methods are acceptable for compliance. The goal is to clarify regulatory expectations and support a flexible, risk-based approach.