Despite the 86-degree temperature and sandy beaches just a couple miles away from the Puerto Rico Convention Center, participants here at ExipientFest in San Juan are huddling down to talk seriously about issues facing the excipient market. Although the percentage of excipients that suppliers provide to companies for use in pharmaceutical products is small compared to other product uses, the importance of pharma companies qualifying their excipients and excipient suppliers is growing. In fact, it may soon be a requirement at every stage in the supply chain.

Dave Schoneker, chairman of the International Pharmaceutical Excipients Council (IPEC) and global regulatory affairs director at Colorcon, spoke about the issues yesterday. IPEC is working very closely with FDA to create a white paper and possible guidance on qualifying excipients to prevent any future contamination crises such as the one that occurred last year when glycerin-based products were found to have lethal levels of DEG, ultimately killing 46 people in Panama. “The days of treating excipients like commodities and buying them without fully qualifying the source…are over,” he said.

Christian Moreton of FinnBrit Consulting and a member of Pharmaceutical Technology’s editorial advisory board, also addressed the DEG contamination issues and sourcing. “A general assumption is that the ‘other’ party is honest … I don’t think we can make that assumption anymore,” he said.

As pointed out by Schoneker and Moreton, “change” is the focus of the excipient industry right now. In addition to modifications already made by FDA with the issuance of 21 CFR 211.84, which requires among other things testing of all glycerin lots, and by a series of newly distributed IPEC guidelines (www.ipecamericas.com), here are some changes to keep an eye out for in the near future:

• An FDA guidance on quality control of pharmaceutical ingredients
• A component on GMPs for excipients in ICH Q7b
• IPEC guidelines on the selection of excipients by the user and on negotiating acceptable specs and quality agreements for excipients
• Changes in FDA inspections. According to Schoneker, “Usually, FDA asks a company if it has an excipient supply audit program at the end of an inspection, and the firm says ‘yes,’ and that’s it. The new question is going to be, ‘Do you have qualified full supplier information on every ingredient used in your product?’”
• Change in expectations: According to Schoneker, pharma companies are going to be held ultimately responsibly for the excipients used in their products no matter where they come from or how many distribution channels they went through. In addition, companies are going to have to research excipient suppliers in much more detail—looking for excipients that simply meet specs or that are the least expensive won’t cut it anymore.
• The focus on QbD may influence what formulators look for in excipients (i.e., various functionality, experimental effect on product, well-defined control and change control, etc.)
• More third-party audits of excipient suppliers
• Potential use of excipient pedigrees via a verified paper trail.

Perhaps Linda Herzog of Mutchler put it best in a talk about supply-chain integrity and excipient distribution, when she said, “They are going to be big changes, so consider yourself warned.”