How the Most Trusted Reference Standards are Developed

Developing USP monographs and official Reference Standards is a collaborative process between USP, manufacturers and expert committees made up of volunteer experts from industry, health care practitioners, academia and government. We take this collaborative and rigorous approach to ensure USP Reference Standards reflect the highest quality in the industry — because helping you comply with quality requirements is one of our chief goals. At USP, we advance quality to build a healthier tomorrow.

Learn more about the collaborative intelligence built into our standards.

From industry need to standard: The USP Monograph and Reference Standard development process

You’re getting more than just a vial when you purchase an official USP Reference Standard. You’re getting the confidence of knowing that you are working with a trusted organization that offers a unique combination of standards, process and service to help you on your journey to regulatory compliance. Since 1820, our standards have been used to facilitate the development and production of drugs used to support the quality of drugs in the United States and more than 140 other countries.

Only USP Reference Standards are linked to official USP monographs that definitively describe the specifications for the identity, purity and potency of the drug. When USP or NF tests or assays require the use of a USP Reference Standard, only those test results obtained using the specified USP Reference Standard are conclusive.

We deploy a thorough, rigorous and open review process to develop all our monographs and Reference Standards, leveraging the knowledge and expertise of leading scientific experts around the world. Expert Committees of scientific volunteers from industry, health care, academia and regulatory authorities review and approve our standards. And, we invite you and other industry stakeholders to contribute by sharing your perspectives during a public comment period through the Pharmacopeial Forum. As a result of our comprehensive process, you can have confidence in our standards and a strong foundation to support public health.

Additionally, once you have purchased a standard, you have access to our in-house scientific experts to answer general questions to help guide you on the path to compliance. We also support you with Reference Standard releases, publication announcements, educational courses and helpful tips. We deliver outstanding ongoing support and training globally and take pride in your satisfaction.