IPEC Conference Creates Excitement about Excipients

Alexandria, VA (Sept. 10–11)-More than 100 people attended this week’s Regulatory Affairs Conference by the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) to discuss the latest trends and challenges in the excipient supply chain. Industry was highly represented at the two-day conference, held in Old Town Alexandria’s Embassy Suites. So were the US Food and Drug Administration, with 10 officials in attendance, the US Pharmacopeia, and the European Pharmacopoeia.

Right off the bat, presenters pointed out that there is no official “excipient industry,” making hot topics such as harmonization difficult to tackle. But that isn’t keeping excipient manufacturers and users from taking a more global approach to their work.

Compendial harmonization was the topic of several presentations, including one by IPEC-Americas Chair-Elect Janeen Skutnik. She advised that excipient manufacturers take ICH Guidelines into consideration when assessing their risk-management processes. With 2000 monographs in the European Pharmacopoeia alone and hundreds of test methods for excipients, mutual acceptance of the global pharmacopeias could go a long way toward reducing duplicate and even triplicate testing of raw materials. Harmonization also could conserve financial resources, Skutnik said.

Another primary topic of conversation at the conference was the launch of IPEC-Americas’ Phase I Guideline on Qualification of Excipients for Use in Pharmaceuticals. Focused on the excipient manufacturer’s process, the guideline is meant “to establish the information needed to support the introduction of a material marketed as an excipient to the pharmaceutical industry” and “to indicate the steps used to establish the requirements for use of an excipient by the pharmaceutical company.” Phase II (about the user’s process) and Phase III (about the negotiation process between excipient producers and users) are expected later this year.

“This is really an umbrella guideline that allows all the other guidelines we have to work in sync,” said IPEC-Americas Chair David R. Schoneker about the new guideline. “More people have been involved in this effort than any committee or effort IPEC has had to date.”

Other conference highlights:

• An IPEC New Excipient Evaluation Panel, in line with FDA’s inspection goals, will soon be underway to review new excipients in hopes of saving manufacturers time and money, eliminating unnecessary toxicity testing, and easing FDA reviews.

• IPEC-Europe is working closely with the European Pharmaceutical Commission to develop good manufacturing practices for excipients.

• An IPEC Foundation is being established to promote research and education related to excipients. The foundation, which is slated to start work by the end of 2007, will collaborate closely with the newly formed National Institute for Pharmaceutical Technology and Education (NIPTE) to provide excipient research grants.

• The Product Quality Research Institute Workshop on Excipient Testing and Control Strategies has released its position paper.

• A new TriPEC website will soon feature guidelines, position papers, and committee progress for all three IPEC organizations: the Americas, Europe, and Japan.

• The Excipient Information Package, created by IPEC-Americas in 2005 to improve the user–supplier relationship, is being used pretty widely-and successfully-in place of typical long questionnaires often provided by excipient users to excipient suppliers to gather data about the material being purchased and used in pharmaceuticals. IPEC-Americas hopes the so-called “EIP” will soon be an industry standard.

As shown, a number of worldwide initiatives were announced in just two short days at the annual regulatory conference. In the words of Schoneker, IPEC is growing and “changing to address the new paradigm” in the pharmaceutical industry. Judging by the reactions of those attending the conference, pharmaceutical company representatives and regulators alike seem to be on board to meet the goals ahead. Click here for more information.