FeedHome » Selling a chemical as USP grade
Print pageSelling a chemical as USP grade
Q: I produce a chemical that, when tested, meets the requirements in the USP for the excipient grade. Can I sell this chemical as USP grade?
A: Irwin Silverstein answers:
Selling a chemical in compliance with an excipient monograph in the USP requires compliance to two elements: First the chemical must meet the specification listed in the monograph, and second, the chemical must have been produced using appropriate GMPs. Since this is an excipient, the chemical must be produced in conformance to the requirements of <1078> of the USP.
You need to review the requirements for GMP listed in <1078> and determine how they apply to the manufacture of your chemical. Compliance need not be an expensive or intrusive burden. If your facility is ISO 9001 compliant, the extra requirements for excipient GMP compliance are manageable.