By engaging with this pipeline, companies can:
Set the standard for quality with monograph donations
By donating your drug substance or drug product specifications, analytical methods, and related Reference Standard candidates, a company can help define global quality benchmarks and build upon its legacy of innovation, enhancing its reputation as a leader in shaping the future of trusted, quality medicines. Let science be the reference for tomorrow’s quality standards.
Advance solutions faster with USP Emerging Standards*
USP’s Emerging Standards program is an agile, iterative approach to standards development designed to adapt to today’s rapidly evolving pharmaceutical landscape and emerging industry challenges. Through this program, Emerging Standards – potential standards in the initial development phase – are shared with the scientific community to stimulate dialogue and participation (e.g., browse, test, and apply Emerging Standards, submit comments, contribute information, share Emerging Standards, and donate methods), which may contribute to these documents potentially achieving official status in the future by going through USP’s official standards-setting processes.
Be part of the science behind the standards by providing input before publication in PF
Scientific expertise and advancement are at the root of USP’s work to develop quality standards and the foundation of all our related activities and programs that help ensure the quality and safety of medicines, dietary supplements, and foods around the world. Companies that donate drug substance or drug product specifications, analytical methods, and related Reference Standard candidates can help define global quality benchmarks and demonstrate their commitment to innovation, enhancing their reputation as a leader in shaping the future of trusted, quality medicines.
Your feedback matters: Provide input on monographs through PF before they become official
PF is a free bimonthly online journal where USP publishes draft proposed standards, including new standards and revisions to existing standards – each intended for inclusion in USP–NF – for public review and comment. New issues of PF are published every two months, at the beginning of the month, with comment periods generally lasting 90 days.
Trust USP official monographs to ensure the quality, safety, and consistency of medicines
USP creates and continuously revises USP–NF standards to help ensure quality in pharmaceutical development and manufacturing. During this process, USP collaborates through a unique public-private collaborative process with pharmaceutical scientists in industry, academia, and government, as well as other interested parties from anywhere in the world, on USP-NF monographs, general chapters, and other USP-NF standards-setting initiatives.
Rely on USP Reference Standards and Analytical Reference Materials recognized by regulators around the world
Successful testing and release of small molecule drugs requires accurate and precise analysis using validated methods and well characterized materials. USP’s independently vetted, science-based Documentary Standards, Reference Standards and Analytical Reference Materials enable manufacturers to operate with a high level of certainty and confidence in their analytical results, saving time and money and reducing risk – from early drug development through post-market release.
* Emerging Standards are not official USP Standards. Some may eventually lead to official USP documentary standards.