Capsugel awarded EXCiPACT certification.
Capsugel has received EXCiPACT certification for its sites in Bornem, Belgium, and Colmar, France. The certification provides independent validation of excipient GMPs and complies with current EU regulations in the manufacturing of empty, two-piece hard capsules.
"Quality and compliance have always been core values at Capsugel--and the keys to our trusted place in the industry," said Anthony Macci, senior vice president of Global Operations at Capsugel. "Capsugel sites worldwide operate above and beyond regulatory parameters and GMP guidelines. This certificate provides Capsugel with third-party validation of our compliance with EU GMP guidelines for these sites."
"On-site auditing to confirm compliance with health authority regulations can be time-consuming and costly for both excipient manufacturers and their customers. In response, IPEC Europe, IPEC Americas, FECC, EFCG and PQG created EXCiPACT as a rigorous, independent, third-party audit system to respond to these regulatory requirements and reduce the audit burden for both sides," said Iain Moore, Ph.D., chair of the EXCIPACT board of directors. "EXCiPACT certification offers an extra level of quality reassurance to customers and, ultimately, patients and consumers."