07.31.13
Merck KGaA has successfully completed an EXCiPACT audit, which ensures current GMP and GDP requirements for pharmaceutical excipients through a certification process covering quality management systems, manufacturing, testing and release, and storage and distribution. The certification is designed to reduce the time and costs for pharma companies to comply with GMP regulations, as well as help secure the excipient supply chain.
"Thousands of excipients are present in medicines and the quality of these materials is critical to ensure patient safety," said Burghard Freiberg, senior vice president, Pharmaceutical Chemicals Solutions, EMD Millipore, the life science division of Merck KGaA. "This EXCiPACT audit will assure our customers they are incorporating only the highest quality excipients into their formulations and we have minimized risk in their supply chain. We encourage all manufacturers of excipients to undergo the same audit."
EXCiPACT, launched in 2012, is a voluntary, international certification to provide independent, third party certification of manufacturers, suppliers and distributors of pharmaceutical excipients. EXCiPACT is a project under the International Pharmaceutical Excipients Council (IPEC) Federation, a global organization that promotes quality in pharmaceutical excipients.
"Thousands of excipients are present in medicines and the quality of these materials is critical to ensure patient safety," said Burghard Freiberg, senior vice president, Pharmaceutical Chemicals Solutions, EMD Millipore, the life science division of Merck KGaA. "This EXCiPACT audit will assure our customers they are incorporating only the highest quality excipients into their formulations and we have minimized risk in their supply chain. We encourage all manufacturers of excipients to undergo the same audit."
EXCiPACT, launched in 2012, is a voluntary, international certification to provide independent, third party certification of manufacturers, suppliers and distributors of pharmaceutical excipients. EXCiPACT is a project under the International Pharmaceutical Excipients Council (IPEC) Federation, a global organization that promotes quality in pharmaceutical excipients.