USP’s Active Pharmaceutical Ingredient Verification Program is offered to drug manufacturers and brands worldwide. USP’s program provides a complete evaluation of a firm’s quality system, ensuring that the controls in place are sufficient to control product quality. This approach complements the thorough GMP audit, product testing and continuous surveillance monitoring already conducted by USP.
USP Verified Active Pharmaceutical Ingredients undergo:
- Good manufacturing practice (GMP) manufacturing and facilities audits
- A review of drug substance, manufacturing, and controls (CMC) documentation
- Drug substance laboratory testing for conformance to specifications
- Ongoing change monitoring and surveillance
For more information, please contact USPverified@usp.org