Excipients Step into the Spotlight

Industry and regulatory experts discuss excipient testing, regulatory expectations, supply-chain challenges, and pricing in this Speakers Roundtable. This article contains bonus online material and podcasts.
Jun 02, 2010
Volume 34, Issue 6

During the past few years, industry has come to better understand excipient functionality and variability as well as excipients' role in the drug-product supply chain. As a result, excipient users and suppliers are looking for more even ground regarding the way in which excipients are used and regulated compared with active pharmaceutical ingredients (APIs) and other raw materials. Standard-setting bodies such as the US Pharmacopeia and US Food and Drug Administration are taking notice and starting to widen the curtains when it comes to the use of novel excipients and the qualification of excipient supply and suppliers.

To address these issues, Pharmaceutical Technology moderated a Speakers' Roundtable at the May 2010 ExcipientFest-Americas and International Pharmaceutical Excipients Council (IPEC) Regulatory Conference in San Juan. This article highlights key points made by the panelists*: Rosa Motta, acting branch chief of international compliance at FDA's Center for Drug Evaluation and Research (CDER), Division of Manufacturing and Product Quality; Catherine Sheehan, director of excipients in the Documentary Standards Division of the US Pharmacopeia (USP); Dale Carter, director of global quality, silica, at Huber Engineered Materials and chair-elect of IPEC-Americas; Ranga Velagaleti, manager of regulatory affairs, North America, BASF Corporation; William Busch, senior applications development specialist at Dow Wolff Cellulosics and member of IPEC's quality-by-design (QbD) committee; and Eric Berg, director of supplier quality at Amgen, member of IPEC-Americas Executive Committee, and Rx-360 consortium volunteer.

Excipient usage evolves

PharmTech: Given the recent changes to the excipient industry, from a regulatory perspective, what core challenges arise with the use of excipients in pharmaceuticals?

Panelists (l to r): BASF's Ranga Velagaleti, Dow's William Busch, Amgen's Eric Berg, and USP's Catherine Sheehan. (PHOTO: COURTESY EXCIPIENTFEST)
Motta: Globalization of the excipient supply chain and the variable degree to which excipient quality is managed by drug manufacturers seem to pose the greatest risks. In more complex global supply chains, excipients can readily change ownership multiple times without proper documentation, accountability, or traceability. There is a higher risk to conduct less frequent audits of the most remote sites of excipient manufacturing. The risk of accepting an unsuitable excipient can be magnified by the use of a non-specific identity test and inadequate excipient manufacturer qualification and monitoring programs aimed to support the level of established credibility. Excipient manufacturers are not required to register as drug manufacturers and it remains relatively easy for an ingredient not intended or suited for pharmaceutical use to be introduced into the supply chain.

lorem ipsum