Nonprofit NSF International is launching the NSF Reference Standards Program, through which it will provide chemical reference standards as a service to drugmakers. The new program augments the documentary standards service it already provides.
The chemical reference standards, which are used for comparisons that demonstrate the identity, purity, quality and strength of the subject drugs and ingredients, will be traceable to official U.S. and European pharmacopeial standards, according to an announcement. The program will focus on developing reference standards that are in demand by global customers in the pharma and health supplement industries, says Steven Lane, the program's general manager, in an email. One indication of the global scope of the service is the announcement's availability in Chinese as well as English. Lane says that reference standard pricing will be "favorable" relative to other U.S. and European pharmacopeial standards.
Among characteristics of the NSF reference standards: they will be verified to conform to FDA and European Directorate for the Quality of Medicines & HealthCare regulatory requirements; produced and tested in compliance with current good manufacturing practices; and tested independently by a minimum of three collaborating laboratories.
- here's the announcement