Our Process

USP quality standards are developed with the world’s leading experts who volunteer and serve on the USP Council of Experts. This public standards-setting process invites input from all interested parties. Our Reference Standards are rigorously tested and evaluated by multiple independent commercial, regulatory, or academic laboratories to confirm accuracy and reproducibility.

We are developing standards that are broadly applicable across product families and classes, delivering solutions to address challenges associated with quality and consistency. These standards support analytical testing throughout the product lifecycle.

We are committed to ensuring that our approach is innovative and forward-focused with the science of biologics addressing the needs of stakeholders, including patients, practitioners, industry and regulators.