RJ Lee Group Provides Training to US FDA on Managing Foreign Particulate Contamination in Pharmaceuticals

Members of RJ Lee Group, Inc.’s Biotechnology and Pharmaceutical Services Department conducted a training seminar for U.S. Food and Drug Administration (FDA) field inspectors entitled “Managing Foreign Particulate Investigations.” The seminar, presented by forensic scientists Ms. Karen Smith, Ms. Julia Patterson, and Mr. Michael Gorski, focused on proactive measures for addressing foreign particulate matter (FPM) contamination in pharmaceutical products by using an industrial forensics approach to collect, isolate, classify, and characterize the particles.

“FPM contamination is gaining recognition as a problem in the pharmaceutical industry,” said Biotechnology and Pharmaceutical Services manager Julianne Wolfe in a statement. “We appreciate the FDA’s interest in our technology and the opportunity to assist in their proactive FPM investigations.”

In response to increasing concerns about FPM, pharmaceutical organizations and manufacturers have been developing programs to investigate and prevent foreign particulate contamination. RJ Lee Group conducts seminars at various institutions and manufacturing sites to help with understanding, establishing, or enhancing such programs.

Full announcement found here.