Merck Millipore has announced that Merck KGaA is one of the first companies to undergo and successfully complete a comprehensive EXCiPACT™ audit.
The audit ensures current GMP and GDP requirements are applied to pharmaceutical excipients through a recognized auditing and certification process covering quality management systems, manufacturing, testing and release, and storage and distribution.
This certification reduces the time and money pharmaceutical companies must invest to comply with GMP regulations and will help secure the overall 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, Merck Millipore.
Freiberg continued, "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 chains. We encourage all manufacturers of excipients to undergo the same audit."
Launched in 2012, EXCiPACT is a voluntary, international certification scheme to provide independent, third-party certification of manufacturers, suppliers and distributors of pharmaceutical excipients.
Audits conducted on behalf of the EXCiPACT association will ensure patient safety through supplier quality, while minimizing the overall costs for assessing the excipient supply chain.
EXCiPACT is a project under the International Pharmaceutical Excipients Council (IPEC) Federation, a global organization that promotes quality in pharmaceutical excipients.
"Collaborating with the EXCiPACT association to execute this audit was an important step for our company and our customers," said Matthias Bucerius, Director of Pharmaceutical Raw Materials, Merck Millipore.
Bucerius continued, "Following this positive assessment, we will undergo recertification audits every three years, with annual surveillance audits to ensure the continued safety and quality of our excipients."