IPEC Americas held its annual ExcipientFest in Baltimore last month, and has made available to non-members many of the key presentations from the event. (Access them all here.) Those talks of particular interest to Quality by Design practitioners include:
- “A Vision for Total Excipient Control”: This keynote by FDA CDER’s Steven Wolfgang discusses the challenge of regulating excipients in a time of rapidly increasing imports, and takes a quick look at 2010 product recalls that resulted from excipient impurity. The latter half of his slides emphasize the need for the adoption of PAT and monitoring strategies to achieve better control over excipients.
- Jim Wiltraut of Buchanan Ingersoll and Rooney provides an overview of IPEC’s interactions with Congress and other lawmakers on matters relating to excipient safety and supply chain security.
- USP’s Susan de Mars provides an update on efforts toward global pharmacopoeial harmonization, including hot topics related to excipient monographs.
- USP’s Catherine Sheehan discusses the development of Excipient Performance Chapter <1059>: Excipient QbD as It Relates to Performance and Functionality, and shares planned revisions to the chapter through 2015.
- The University of Maryland’s Stephen Hoag gave a luncheon talk about “Excipient Variability and Functional Testing.”
- Meggle’s Franz Karl Penz presented on “Co-processing and Modelling–Possible Tools for Simplifying Modified-release Formulations.”
–Paul Thomas
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