The International Pharmaceuticals Excipients Council (IPEC) Federation announced in early February the launch of EXCiPACT – its new, voluntary international certification scheme designed and developed to assure cGMP and cGDP standards are being used in the manufacture and supply of pharmaceutical excipients.
Over 150 stakeholders representing developers, manufacturers, suppliers, distributors, and users of pharmaceutical excipients, along with representatives of regulatory bodies and academia, gathered in Barcelona at the end of January for the launch event.
Speakers included regulators from FDA and MHRA and industry representatives from BASF, Croda, Pfizer, SGS and Merck Millipore, who discussed the reasons for creating EXCiPACT and the benefits it can bring to supply chain security, cost saving and patient safety. Emphasis was placed on the training and certification of third party auditors needed to advance the effort.
A new website is available to assist the pharmaceutical industry and supply chain players to learn more about the use and value of EXCiPACT (link provided below). The website provides free access to the EXCiPACT standards, information and guidance on the certification process, auditor training requirements, training sessions and qualifications. Lists of approved third party audit organizations, approved auditors and certified organizations will be added as they become available.
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