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October 3, 2014
By: Lisa Olivo
Capsugel, Morristown, NJ, 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.
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