Capsugel Awarded EXCiPACT™ Certifications for Excipient
Good Manufacturing Practices
First hard capsule manufacturer to receive this important third-party recognition
Morristown, N.J., October 1, 2014 – 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. "Capsugelsites 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 thatprovides 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, CapsugelEMEA. "We are honored to be the first excipient hard capsule manufacturer to be awarded with the prestigious EXCiPACT™ certification."
Capsugel is a global leader in delivering high-quality, innovative dosage forms and solutions to its customers in the health care industry. The company's Hard Capsule business offers customers the broadest portfolio of gelatin, vegetarian, and other specialized capsule technologies. Capsugel's Dosage Form Solutions (DFS) business utilizes an array of proprietary technologies and specialized manufacturing capabilities to solve customers' most pressing product development challenges, including bioavailability enhancement, modified release, abuse deterrence, biotherapeutic processing, and inhalation formulation. The company's fast-to-clinic program streamlines product development from pre-formulation through clinical and commercial supply for finished dosage forms. Headquartered in Morristown, N.J., Capsugelserves more than 4,000 customers in more than 100 countries. For additional information, visitwww.capsugel.com.
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