Not properly assessing quality risks can lead to regulatory actions, product recalls and even patient harm. USP’s Ingredient Verification Program for Active Pharmaceutical Ingredients (APIs) helps ensure the quality of APIs by demonstrating that product quality standards and current Good Manufacturing Practices (cGMPs) are being met for continual improvement.
For APIs, this means complying with regulatory and industry best practices, including ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
This comprehensive 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 APIs helps ensure the quality of APIs 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
