Impact of Heparin Crisis on Public Standards and Regulatory Process

The heparin crisis illustrated the importance of continual modernization of existing
analytical techniques, review process and public standards (e.g., compendial
monographs). In particular, it highlighted the necessity of developing modern orthogonal
analytical methods to assure the quality of marketed products and to facilitate detection
of potential contaminants. Additionally, Office of New Drug Quality Assessment/ FDA
has considered how to leverage learning's from these events, in implementation of
Quality by Design (QbD) concepts in submissions and review. The presentation will
focus on collaboration between FDA, USP and global regulatory agencies in order to
update public standards and the incorporation of Quality Risk Management approach in
the regulatory process for effective evaluation and subsequent assessment of heparin
regulatory submissions.