USP's Reference Standard Team
The internal development and maintenance of the USP Reference Standard collection is directed by USP’s Reference Materials Division.
USP's volunteer Expert Committees approve USP Reference Standards that are created to support compendial monograph and General Chapter procedures. Responsibilities in the approval process include review of relevant data, communication with Reference Standard Scientists to clarify questions related to the presented data, and determination of suitability of the Reference Standard for its intended use.
The committees' work is supported by USP's Reference Materials Division which includes the following departments:
- Standards Acquisition Department
USP's Standards Acquisition Department is responsible for working with donors to source information to support monographs and candidate reference materials for USP’s compendia. The Department also seeks information in support of monograph updating. The Department’s staff are located in USP’s headquarters in Rockville, India, and China.
- Reference Standards Evaluation Department
The Reference Standards Evaluation Department is responsible for the development and maintenance of the entire USP catalog of Reference Standards, including certified reference materials. The Department also operates the Reference Standards Technical Service, which offers global customer support on the proper use of USP Reference Standards. The department is responsible for coordinating all testing of USP’s candidate reference materials, with generation of reports for consideration by the Expert Committees of the Council of Experts.
- Reference Standards Laboratory Group
The Reference Standards Laboratory Group is responsible for the characterization of all candidate reference materials by collaborative testing using established or proposed compendial and other specialized procedures. The Group is the lead among several collaborative laboratories throughout the world, including government laboratories (FDA, Health Canada, Therapeutic Goods Administration in Australia, and provincial laboratories in China), laboratories at USP’s international sites, and contract laboratories.
- Reference Standards Production Group
The Reference Standards Production Group is responsible for the bottling, packaging, and labeling of all Reference Standards and also manages receipt, inventory maintenance, and sampling of all bulk materials, including shipment of samples to collaborative laboratories. After filling and labeling Reference Standards, the Group performs quality control testing on the finished products. RSP also creates and maintains Material Safety Data Sheets (MSDS) and applicable certificates for USP’s reference materials.
- Applied Compendial Research Department
The Applied Compendial Research Department conducts laboratory research to develop and improve compendial methods and related reference materials. It has four component groups: Separation Science Research Laboratory, Spectrometric Research Laboratory, the Dosage Form Performance Laboratory, and the Biologics and Biotechnology Laboratory. The capabilities of the Department are increasingly needed for many reasons, including a) USP’s reference materials are becoming increasingly more complex (e.g., heparin standards); b) USP’s understanding of measurement science (metrology) is advancing rapidly; and c) USP is working more independently to obtain information and candidate materials for new monographs and monograph updating.