FEATURING A SUMMARY OF BEN VENUE ISSUES Policy changes and enforcement strategies implemented by the FDA have led to an increase in the number of inspection of both Contract Manufacturing Operations (CMOs) and in-house sterile manufacturers — especially injectables. There has been a greater oversight and detailed review of all protocols and processes. Any issue or potential … [Read more...]
REVIEW OF SELECTED OBSERVATIONS FROM BEN VENUE FDA 483 (5/25/11)
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...]
