Quality Risk Management of Compliant Excipients

  • Brian Carlin FMC Biopolymer


Raw material compliance and GMP do not eliminate variability. Quality by Design should minimize the risk that raw material variability will adversely affect the finished product Critical Quality Attributes. The sources of technological risk from excipients are reviewed and approaches to excipient risk management are discussed. Supplier involvement throughout the product life-cycle is recommended to minimize excipient-related risk.

Author Biography

Brian Carlin, FMC Biopolymer

Dir Open Innovation FMC BioPolymer

Chair IPEC Americas QbD Committee

Chair IPEC Americas Excipient Composition Committee

How to Cite
CARLIN, Brian. Quality Risk Management of Compliant Excipients. Journal of Excipients and Food Chemicals, [S.l.], v. 3, n. 4, p. 143-153, dec. 2012. ISSN 21502668. Available at: <https://ojs.abo.fi/ojs/index.php/jefc/article/view/190>. Date accessed: 24 july 2024.
Opinion and Commentary