How to Close Foreign Particulate Matter Investigations Quickly and Efficiently

Oliver Valet, Ph. D., Germany, Berlin, Germany

We will discuss basics of proper investigation and control of foreign particulate matter (FPM) to ensure compliance with current good practices (GxP) with special attention to USP chapters <787> and <790>. We will discuss root cause investigation, sampling strategies and comparison of the particle materials with sources from manufacturing or packaging. Investigation of Particulate Matter in Parenterals: Application of Raman and LIB Spectroscopies.