Ingredient Verification Program for Excipients

As the excipient supply chain continues to become more complex, transparency about quality is critical. USP’s Ingredient Verification Program for Excipients strengthens confidence that current Good Manufacturing Practices (cGMPs) and product quality standards have been met for continual improvement.

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For excipients, this means complying with regulatory and industry best practices, including:

  • USP General Chapter <1078> Good Manufacturing Practices for Bulk Pharmaceutical Excipients
  • ANSI 363 Good Manufacturing Practices (GMP) for Pharmaceutical Excipients

The program also helps to qualify suppliers, reduce inspection costs, and decrease the risk of inconsistent or substandard-quality ingredients.

USP’s Ingredient Verification Program for Excipients helps ensure the quality of excipients by:

  • Auditing manufacturing sites for conformance with cGMPs
  • Reviewing quality control and manufacturing (QCM) product documentation
  • Testing product samples in laboratories
  • Monitoring annually with cGMP audits, QCM documentation reports and product testing

See the process

View Participant Manual

View the Ingredient Verification Program for Excipients Participant Manual to learn more.

View Participant Manual

Program Participants

View participants in USP's Ingredient Verification Program for Excipients.

Learn more

Contact Us

Questions about becoming USP Verified? Reach out to us at USPVerified@USP.org or fill out the contact form below and we will be in touch.

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