USP Reference Standards Development Process
The life of a USP Reference Standard begins with a review of the associated documentary standards (monographs and General Chapters), including those in development, to assess compendial uses. Once USP has identified the need for a new Reference Standard, it requests bulk materials from corresponding manufacturers. USP subjects the candidate materials it receives to rigorous analysis and review. USP tests the materials in multiple laboratories including its own and other independent laboratories. USP compares and analyzes the results of this collaborative testing and prepares a report for the voluntary Standards Expert Committees. The committees determine whether the candidate material is suitable for use in associated compendial methods. USP's meticulous packaging, stringent quality control checks, and Continued Suitability for Use testing enhance the quality and integrity of its Reference Standards.
Individual steps in this development process are outlined below. Click on each one for details.
- Identifying the Need for a New Reference Standard
- Procurement of Candidate Materials
- The Collaborative Study
- Data Review
- The USP RS Label Text
- Approval of a Candidate Material as a RS
- Post-packaging Quality Control (QC) and Quality Assurance (QA) Review
- Entry into USP Store and Catalog
- Continued Suitability for Use Program