The presence of foreign particulate matter (FPM) in pharmaceuticals increases the risk of serious adverse patient reactions. FDA has penalized some of the world’s leading manufacturers for failing to meet cGMPs in this area, and many drugs have been recalled due to FPM contamination.

Today, compendial testing for FPM occurs largely as “Quality by Inspection,” at the end of the production cycle. This is especially problematic since visible FPM contamination in products can occur when sub-visible particulates aggregate, agglomerate, precipitate or settle during transportation, after they have been tested at the manufacturer’s QC lab. Thus, the contamination only becomes visible after products have been released and shipped. Thus, new methods are needed to characterize FPM.

In this article, Julianne Wolfe, Karen Smith, and Linxian Wu of RJ Lee Group propose a system to extend Quality by Design (QbD) methodology to this critically important area of pharmaceutical quality control. They consider a tiered, forensic characterization based upon three major components: Optical Microscopy, Fourier Transform Infrared Spectroscopy (FTIR), and Scanning Electron Microscopy/Energy Dispersive X-ray Spectroscopy (SEM/EDS).

Access the full article.

(Note: This article appears as a two-part series in the October 2011 and November/December 2011 issues of Pharmaceutical Manufacturing magazine.)

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