9/10 February 2023
EXCiPACTTM is currently the most frequently used standard for the auditing and certifying of excipients and their production sites. This standard was started in January 2010 by the EXCiPACT Association (composed of members of the EFCG, FECC, IPEC-Europe, IPEC-Americas and PQG). Since then, it has been rigorosly tested in the framework of a pilot phase. According to a press release published by the EXCiPACT Association in July 2013, the pilot phase recently ended with the award of the first two certificates to two German manufacturers and distributors of pharmaceutical excipients issued by a accredited Third Party Audit Organisation.
The provisions of the ISO 9001:2008 standard are the basis and framework of EXCiPACTTM. The specific GMP and GDP requirements for the manufacture and distribution build up on them. They are optimised for the particular situation of excipients facilities which usually distribute only a small part of their products to the pharmaceutical industry and in many cases have already an ISO certification.
EXCiPACTTM is a quality standard for the manufacture, storage and transport of excipients which is now recognised by authorities and the industry worldwide. It has been made available to the industry at a time when the regulators in the EU and USA required the holders of the marketing authorisations for medicines to ensure that appropriate GMP and GDP is applied to the manufacture and distribution of both APIs and excipients.
GMP/GDP for pharmaceutical excipients is a very serious topic for the authorities. The Compilation of Community Procedures on Inspections and Exchange of Information was already released on 27 June 2013 with updates regarding the performance of GDP inspections.
The EXCiPACTTM standard can be found here.