Some of the discussion will focus on excipient qualification and proposed good manufacturing and good distribution standards for developing and using excipients in human drug products (see page s40 of our May supplement for the full story). Another talking point will revolve around novel excipients. Many manufacturers are afraid to develop or use a new excipient because of the related regulatory hurdles, which is leaving many complex drugs that could use a new, better excipient in the lurch. IPEC recently proposed a novel excipient safety evalution procedure (see our November 2009 issue) and is awaiting regulatory and industry feedback.
Finally, the roundtable will address the notion that excipient suppliers who do not apply a risk-based approach to their quality control and supply-chain security programs should not be allowed to sell their excipients at lower cost. In other words, the price should reflect the material's quality and safety (or should it?).Find out which debates were resolved and which myths were proven wrong in next month's cover story. With excipient suppliers, users, and regulators in the audience, the roundtable is likely to turn into quite a heated debate.
Angie Drakulich is managing editor Pharmaceutical Technology.