European trade bodies jointly create an excipients certification project

The European Fine Chemicals Group (EFCG) and the International Pharmaceutical Excipients Council (IPEC) announced at CPhI that they have formed a European Pharmaceutical Excipients Certification Project to ensure that all products in their sector meet the highest quality requirements.

The move follows the signing of an agreement back in June that the two associations would collaborate on the development of a certification programme covering Good Manufacturing Practices (GMP) for manufacturers and distributors of pharmaceutical excipients.

Several recent incidents concerning both pharmaceutical excipients and active pharmaceutical ingredients have highlighted the serious risk to patients that arises when the quality of pharmaceutical raw materials has been compromised.

In the absence of any regulations that require GMP and GDP for excipients, some manufacturers believe there is a critical need for the excipient industry to demonstrate a commitment to the delivery of high quality products throughout manufacture and distribution.

According to the EFCG and IPEC Europe, two Certification project teams are to be created: one will cover excipient classification (with global scope) and a European certification scheme; the other, will comprise an Audit Team that will tackle European auditor competency and certification. It is intended that this will include involvement from the 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 PQG, are developing a certifiable, global standard, under the guidance of an IPEC/PQG steering committee.

This excipient certification programme is being developed in conjunction with other trade associations worldwide who have a similar interest in pharmaceutical excipients. The aim is to achieve a truly international certification programme.

The EFCG said it welcomes recent actions taken by the regulatory authorities on both sides of the Atlantic and in Japan to stem the flow of sub-standard and counterfeit APIs and medicines in the wake of the heparin disaster earlier this year.

"While enforcement, and the perception of enforcement, is now becoming much more effective, we must continue to urge the regulators to increase their efforts to deter the rogue players in the API supply chain", says Guy Villax, EFCG Board member and CEO of Hovione.

He added: "We are particularly looking forward to the European Commission's legal proposal to combat counterfeit medicines due in October, as their concept paper included many of the regulatory improvements we have been asking for, especially a much more demanding inspection regime for GMP compliance of API manufacturers in higher-risk countries with lower standards than the EU".