ExciPACT certification demonstrates Capsugel's manufacture of compliant, safe and high-quality pharmaceutical excipients. The scope of the award also covers the manufacturing of empty hard capsules.
Pharmaceutical regulations require the manufacturers of drugs and other related products to commission audits, either internal or conducted by a third-party, to prove GMP compliance. The ExciPACT certification scheme allows manufacturers, suppliers and other stakeholders to assure safety and quality through a simplified audit process.
A complex assessment process was undertaken by SGS and Capsugel's auditors to become ExciPACT-registered. Capsugel's auditors also completed the two-day ExciPACT Auditor Training course and a written examination to demonstrate that their knowledge and competency satisfied the requirement of the standard. As part of the process, SGS also had the internal auditor's report verified by a third-party certification board before any certificate could be issued.
Jeff Dowson, SGS Global Head of International Sales and Accounts, noted the significance of this certification, and said: "Capsugel was able to showcase their dedication to compliance, quality and risk-reduction for their stakeholders and customers in terms of pharmaceutical manufacturing. At the same time, we were able to show our expertise and dedication to certification and standards. We believe in the importance of assuring the safety of the pharmaceutical supply chain."
For more information, please contact:
Global Head of International Sales and Accounts
t: +44 7889 939 725