USP’s Ingredient Verification Program for Excipients has been revised to add a more risk-based, holistic approach to quality, through an in-depth examination of how quality decisions affect the final product. By incorporating a thorough review of a participant’s manufacturing batch records and product release data, 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’s goal is to ensure our service adds value by offering a high level assurance of quality to your customers.
Our upgraded program encompasses the following:
- Revised scope to include risk-based assessments throughout the verification process
- GMP requirements based on USP ‹1078› Good Manufacturing Practices for Bulk Pharmaceutical Excipients and NSF/IPEC/ANSI 363 – Good Manufacturing Practices (GMP) for Pharmaceutical Excipients
- Review of the manufacturer’s risk assessment plan and mitigation controls
- Review of supply chain controls