EFCG and IPEC Europe Establish an Excipient Certification Project

Brussels (Sept. 30)-The European Fine Chemicals Group (EFCG) and the International Pharmaceutical Excipents Council of Europe (IPEC Europe) announced the formation of  a European Pharmaceutical Excipients Certification Project to develop advocacy and stakeholder management in Europe and to give advice to two European working teams as part of an effort to develop a certification program for manufacturers and distributors of pharmaceutical excipients. The associations made the announcement at a press briefing at CPhI Worldwide, the large pharmaceutical ingredients exhibition, which was held in Frankfurt last week.

EFCG and IPEC Europe signed a memorandum of understanding in June 2008 to foster close collaboration  between the two associations for developing a certification program covering good manufacturing practices (GMPs)  and good distribution practices (GDPs) for manufacturers and distributors of pharmaceutical excipients.

Under the European Pharmaceutical Excipients Certification Project, announced last week, a certification team will cover excipient classification with a global scope and a European certification scheme. An audit team will address European auditor competency and an assessment-body certification, with the suggested involvement of European regulatory agencies. A European stakeholder workshop is being planned for early 2009 to review the progress of these two teams.

In parallel, IPEC Americas, IPEC Europe, and the Product Quality Group (PQG), are developing a certifiable, global standard under the guidance of an IPEC–PQG steering committee. This excipient-certification program is being developed in conjunction with other trade associations worldwide that have a similar interest in pharmaceutical excipients. “This should result in a truly international certification program,” said IPEC Europe and EFCG in a joint press release.

EFCG is a sector group of the European Chemicals Industry Council (CEFIC). It was formed in 2004 to represent the interest of European fine chemical manufacturers. IPEC is the global association of manufacturers and users of pharmaceutical excipients. The association consists of three closely related but independent associations: IPEC-Americas, IPEC-Europe, and IPEC Japan.