Failure Mode and Effect Analysis (FMEA) as a Quality by Design (QbD) Tool for Managing Biopharmaceutical Product Development and Manufacturing Risks

by Mark F. Witcher, PhD
Volume 13, Issue 3 (Fall 2014)

This paper examines FMEA as a QbD tool. If FMEA’s strengths are used and weaknesses understood, it can be effectively used within a QbD feedback algorithm to identify, analyze, prioritize, and remediate biopharmaceutical development and manufacturing risks.

Witcher MF. Failure mode and effect analysis (FMEA) as a quality by design (QbD) tool for managing biopharmaceutical product development and manufacturing risks. BioProcess J, 2014; 13(3): 39–46.

Posted online October 13, 2014.