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EXCiPACT announces that DQS awarded Grace GmbH an EXCiPACT Certificate for its Worms, Germany excipient-manufacturing site.
On June 17, EXCiPACT announced that one of its certification bodies, DQS, awarded Grace GmbH an EXCiPACT Certificate. Grace’s excipient manufacturing facility in Worms, Germany was deemed to meet the expectations of the EXCiPACT GMP certification standards. The certification at this site marks the eighth site to be certified in Germany, and the 20th to be certified worldwide.
Drug manufacturers in the US and the EU must complete individual physical audits or commission a third party to complete an audit of all starting material suppliers to “demonstrate GMP and/or GDP compliance thus increasing the audit burden. Using GMP and GDP standards designed for excipients, the new, high quality third party EXCiPACT Certification Scheme is already helping excipient users and suppliers to reduce their audit burden, save costs, and assure quality,” according to a press release. According to the EXCiPACT website, (http://www.excipact.org/about-us/) the organization was designed to provide excipient manufacturers with certificates to minimize audit burdens and costs in assessing cGMP and cGDP standards throughout the excipient supply chain while maintaining quality and patient safety.