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Capsugel has received EXCiPACT certification for its sites in Bornem, Belgium, and Colmar, France.
Capsugel has received EXCiPACT certification for its sites in Bornem, Belgium, and Colmar, France. The certification provides independent validation that Capsugel maintains excipient GMPs and complies with current EU 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, in a press release. Macci added that the certification provides Capsugel with third-party validation of the company’s 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.”