Capsugel announced today that it has received EXCiPACT™ certification for its sites in Bornem, Belgium, and Colmar, France. The certification provides independent validation that Capsugel maintains excipient Good Manufacturing Practices (GMPs) and complies with current European Union regulations in the manufacturing of empty, two-piece hard capsules. Capsugel is the first hard capsule manufacturer to receive EXCiPACT™ certification.
“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.”
EXCiPACT™ is an independent not-for-profit association that provides management oversight for independent, third-party certification of manufacturers, suppliers and distributors of pharmaceutical excipients worldwide. EXCiPACT™ selects independent, third-party accredited certification bodies, employing ISO 9001 qualified auditors who also have to meet EXCiPACT™ auditor competency requirements. Capsugel received its certificates from SGS, one of EXCiPACT™’s internationally recognized certification bodies.
“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, PhD, Chair of the EXCIPACT board of directors. “EXCiPACT™ certification offers an extra level of quality reassurance to customers and, ultimately, patients and consumers.”
“Capsugel strives to maintain internal quality and compliance policies that remain a step ahead of current regulations,” said Kaat Bracquiné, Quality Control Compliance and Regulatory Manager, Capsugel EMEA. “We are honored to be the first excipient hard capsule manufacturer to be awarded with the prestigious EXCiPACT™ certification.”
