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. Access the USP Guideline for Donors of USP Reference Standard Candidate Materials.
- By testing candidate materials provided by USP in your laboratories. This testing is integral to USP's characterization of USP 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 firstname.lastname@example.org.
The Reference Standards Development Process
Establishing a USP Reference Standard begins with the need for bulk material stemming from the development of a new monograph, a new application of an existing monograph or standard, 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 about the development process.
Industry involvement in the USP Reference Standards Program is critical to producing the best 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 Reference Standards
- Interact with USP's expert staff and volunteer scientists who can guide you in enhancing your internal quality control processes
Beginning on January 1, 2016, donors of new or modernized monographs and candidate reference materials may receive, at their discretion, Certificates of Appreciation when monographs reach the publication in forum stage or when donated reference materials are received. Reference material donors may also receive one packaged vial of their RS and a summary of the data collected by USP on their candidate material at the time of release, recognition in USP publications and a personalized crystal statue, a symbol of recognition for their contribution to public health.
Please note: Candidate reference standard material submissions after May 15, 2015, are unlikely to reach recognition milestones within the 2015 calendar year, and will instead be eligible for 2016 recognitions. Changes to the recognition structure are expected in 2016. Look for the 2016 Recognition Chart coming soon.
USP is also interested in your ideas for new Reference Standards. To submit an idea, click here.
USP Donor Recognition Program
Learn about USP's Donor Recognition Program here.