Excipients step into the spotlight in this podcast series, addressing novel excipients, the role of heavy metals, pricing, and more.
In May 2010, Pharmaceutical Technology moderated a Speakers’ Roundtable at the ExcipientFest-Americas and IPEC Regulatory Conference in San Juan, to discuss excipient use and regulation. On the panel were: FDA’s Rosa Motta, USP’s Catherine Sheehan, IPEC and Pfizer’s Janeen Skutnik, IPEC and Huber Engineered Materials’ Dale Carter, Dow Wolff Cellulosics’ William Busch; Amgen and Rx-360’s Eric Berg, BASF’s Ranga Velagaleti, Anchen’s Sherry Ku, and Moderator Angie Drakulich of Pharmaceutical Technology.
This portion of the roundtable provides an introduction to the topic and to the panelists. Plus, the panel discusses recnt changes to the excipient industry, FDA's current expectations regarding excipient understanding and control, and supply-chain challenges, including the ability and expectation to audit every supplier.
Panelists address the IPEC novel excipient evaluation procedure, including USP's role in the pilot program, and FDA's take on the use of novel excipients.
Panelists address the proposed USP heavy metals revisions, the ICH expert working group on elemental impurities, and the controversy regarding supplier qualification versus material price.
In this final portion of the roundtable, audience members question the panelists about the use of--and FDA expectations for--paper audits, expanding the Inactive Ingredients Database, and more.
Read the print version of this roundtable, a Q&A report, that appeared in the June 2010 issue of Pharmaceutical Technology.