MEDIA FILL OBSERVATION GATHERS 8 "SUBOBSERVATIONS" COMMENT Enclosed are the initial four Subobservations from the audit surrounding the Media Fill Program.  Where possible FDA's 2004 Aseptic Processing Guidance is referenced.   OBSERVATION 3 The "Media Fill Program Parameters and Specifications" document #030-SOP-029, and the "Outlining Test Parameters and Specifications … [Read more...]