IPEC Federation launches EXCiPACT
New certification scheme for pharmaceutical excipient manufacturers and distributors
The International Pharmaceutical Excipients Council (IPEC) Federation has launched EXCiPACT, a new certification scheme for pharmaceutical excipient manufacturers and distributors.
The voluntary international certification scheme has been designed and developed to assure that cGMP and cGDP standards are being used in the manufacture and supply of pharmaceutical excipients.
EXCiPACT is expected to bring benefits to supply chain security, cost saving and patient safety. It is an independent, non-profit legal entity, registered in Brussels. Since 2008, it has been developed as a project via a consortium of industry experts from the European Fine Chemical Group (EFCG), the European Association of Chemical Distributors (FECC), the International Pharmaceutical Excipients Council (IPEC) Europe, IPEC-Americas, and the UK Pharmaceutical Quality Group (PQG).
EXCiPACT’s vision is for the scheme to be a voluntary, self-regulated initiative of the global pharmaceutical excipient manufacturing, distributing and pre-formulating industry, supported by excipient users.
The EXCiPACT website is available to assist the pharmaceutical supply chain to learn more about the use and value of the scheme.
The website provides access to the EXCiPACT Standards, a brochure, the launch slides, 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.