New Inspection Protocol for Sterile Injectable Drugs

On November 9, 2018, the FDA announced new steps to modernize its pharmaceutical manufacturing inspections program with a new way of assessing, recording, and reporting the data from surveillance and pre-approval inspections for sterile drug products.


This New Inspection Protocol Project (NIPP) uses standardized electronic inspection protocols to collect data in a structured manner for more consistent oversight of facilities and faster and more efficient analysis of findings. The protocols also include additional questions related to quality culture observed in facilities. The new tool is being applied to FDA inspections related to sterile injectable drugs, which have been the subject of sterility problems and shortages in the past. The primary focus of this new tool is to ensure more streamlined and consistent coverage and reporting of the FDA’s inspection activities.


These aseptic processing drug inspection protocols for sterile drugs are the first of what the FDA plans to be a series of valuable new inspection protocols covering all dosage forms. As the FDA integrates what it learns from these pilots in field activities, the FDA’s goal is to have them ready for full implementation within the next two years.


See the FDA Announcement


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