IPEC-Americas has announced the successful US launch of EXCiPACT, a voluntary international certification scheme designed and developed to assure cGMP and cGDP standards are being used in the manufacture and supply of pharmaceutical excipients.
Approximately 100 stakeholders representing designers, manufacturers, suppliers, distributors and users of pharmaceutical excipients, plus regulatory bodies and academia, gathered in Maryland on 29 April 2013 for the launch event during ExcipientFest. They heard and interacted with speakers from the FDA, J.M. Huber Corporation and Hedinger GmbH & Co., who discussed the reasons for creating EXCiPACT and the benefits it can bring to supply chain security and patient safety. Much emphasis has been placed on the training and certification of third party auditors to deliver the scheme.
A website, www.excipact.org, is available to assist the pharmaceutical supply chain to learn more about the use and value of EXCiPACT. In addition to useful background information, the website provides access to the EXCiPACT standards, information and guidance on the certification process, plus auditor training requirements, training sessions and qualifications. Lists of approved third party audit organisations, approved auditors and certified organisations will be added as they become available.
IPEC Federation, EXCiPACT Association, +44 1786 220000, info@exipact.org, www.exipact.org.