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.
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
