Merck KGaA passes EXCiPACT audit for certification as provider of excipients

Certification minimises risks for customers and improves patient safety

Merck Millipore, the life science division of Merck, says Merck KGaA has successfully completed an EXCiPACT audit to ensure the quality of its pharmaceutical excipients.

The audit uses a recognised auditing and certification process to assess quality management systems, manufacturing, testing and release, and storage and distribution of 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, Merck Millipore.

‘This EXCiPACT audit will assure our customers that they are incorporating only the highest-quality excipients into their formulations and we have minimised risk in their supply chains.’

Launched in 2012, EXCiPACT is a voluntary, international certification scheme to provide independent 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 minimising the overall costs for assessing the excipient supply chain.

EXCiPACT is a project under the International Pharmaceutical Excipients Council (IPEC) Federation, a global organisation 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. ‘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.’