FDA Moves to Modernize Inspections for Sterile Injectables

November 28, 2018

The FDA is streamlining its reporting of inspections for sterile injectable drugs to help make risk-based regulatory decisions.

The New Inspection Protocol Project will use standardized electronic inspection protocols to collect better data, so the agency can use data analysis to flag issues that could, for example, lead to supply shortages. In the project’s completed first phase, the agency developed a protocol for aseptic processing surveillance and pre-approval inspections of sterile drug facilities.

Commissioner Scott Gottlieb said facilities using the processing technique to manufacture sterile drug products were “a logical starting place because of the significant impacts on patient safety if the quality of drugs … intended for sterile injection are compromised.”

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