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Excipient manufacturing site achieves EXCiPACT certification following regulatory inspections.
Colorcon announced on May 28 that the company had been awarded EXCiPACT certification for its excipient-manufacturing site in Dartford, UK.
“EXCiPACT is an additional certification scheme for pharmaceutical excipients that demonstrates to customers our continued commitment to quality and managing risk on their behalf. Colorcon views EXCiPACT as a complementary element of our pledge to continuous improvement of our already established quality systems helping our customers reduce total cost of ownership,” said David Bain, Managing Director, Colorcon Europe.
To achieve the certification, Colorcon aligned its quality management system with the Joint International Pharmaceutical Excipient Council (IPEC)-Pharmaceutical Quality Group (PQG) Good Manufacturing Practices Guide for Pharmaceutical Excipients. Compliance with the IPEC-PQG Guide was confirmed through voluntary GMP inspections with the UK Medicines and Healthcare Products Regulatory Agency. The company facility was inspected and meets the requirements of appropriate licensing bodies around the world, Colorcon reports in a statement.
Colorcon is a founding member of the International Pharmaceutical Excipient Council (IPEC)