Active Pharmaceutical Ingredient Verification Program

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 facility audits
  • A review of quality control and manufacturing (QCM) documentation
  • Active pharmaceutical ingredient laboratory testing for conformance to specifications
  • Ongoing change monitoring and surveillance

For more information, please contact

Verification Manual  Active Pharmaceutical Ingredients Verification Participants Learn More

Pharm Tech podcast

COVID-19's impact on FDA inspections and manufacturer risk.

Read the article