EXCiPACT launches in the US
International GMP and GDP certification scheme for pharma excipients extends its coverage
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, has now been extended to the US. The scheme was first launched in Europe in January 2012.
Approximately 100 stakeholders representing designers, manufacturers, suppliers, distributors, and users of pharmaceutical excipients, plus regulatory bodies and academia, attended the US launch event in Maryland on 29 April 2013 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, cost saving and patient safety. Much emphasis has been placed on the training and certification of third party auditors to deliver the scheme.
A website is available to enable 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.