Get Involved in Establishing USP Reference Standards

Establishing USP Reference Standards involves the voluntary cooperation of three groups: industry, government, and USP. Industry can participate in the process in the following ways

• By supplying a bulk quantity of drug substances, dosage forms, excipients, or other material to support documentary standards or monographs. These materials will serve as candidates for official USP Reference Standards. Download the USP Guideline for Suppliers of Reference Standard Materials  (69KB).
• By testing candidate materials provided by USP in your laboratories. This testing is integral to USP's characterization of official Reference Standards.

To assist participants through each step of the process, USP has a dedicated Standards Acquisition team of scientists and support staff. Contact the team at .

The Reference Standards Development Process

Establishing an official USP Reference Standard begins with the need for bulk material stemming from the development of a new monograph or depletion of current inventory. Once USP has acquired a bulk material donation from a manufacturer, the material undergoes rigorous, collaborative testing by at least three laboratories. Read more and view the development process chart.

Participant Benefits

Industry involvement in the USP Reference Standards Program is critical to producing the best official reference materials. Supplying bulk candidate materials and/or providing testing services for USP Reference Standards helps you

• Qualify for tax benefits for the value of the materials you donate to USP
• Prepare for regulator inspections, based on familiarity with official requirements
• Contribute to quality in public health worldwide by helping to ensure the continuous availability of official Reference Standards
• Interact with USP's expert staff and volunteer scientists who can guide you in enhancing your internal quality control processes

USP is also interested in your ideas for new Reference Standards. To submit an idea, visit www.usp.org/referenceStandards/industryParticipation/newIdeas.html.