Wolfe , J. and K. Smith, “Forensics in QbD: Addressing Foreign Particulate Matter Investigations”, American Pharmaceutical Review, 2014.
Foreign particulate matter (FPM) can affect product efficacy, but more critically, it can affect product safety leading to recalled product or regulatory action (eg, FDA warning letter). FPM investigations can be costly and sometimes inconclusive which complicates decisions about product release. There are ways to streamline these investigations through an approach in line with Quality by Design (QbD). Particulate programs couple the right characterization technique, a proven method for historical data organization, more enhanced manufacturing process understanding, and risk-based decision making. These attributes of a particulate program come together to enhance the quality of FPM investigations in a manner that is cost effective, efficient, and, most importantly, conclusive.