FDA Endorses Automated Inspection of Particulates in Injectable Drugs

The FDA offered advice on designing a visual inspection program to ensure injectable drugs are free of visible particulates in a new draft guidance, noting that automated inspections may be more reliable than visual inspections by humans.

In the 18-page guidance, Inspection of Injectable Products for Visible Particulates, the agency said the visual inspections may be manual, semi-automated or fully automated.

Automated inspections can be used to either replace manual inspections or as “an additional quality insurance step,” the agency said, noting that automated technology can use specific wavelengths and sensors to find hard-to-see particulates, especially in sterile powder, suspensions or light-protected injectables for which “visual inspection is not completely effective.”

“When compared with manual inspection, automated inspection technology may improve detectability of visible particulates because machine variability is generally easier to control than the variability individual personnel can bring to tasks performed repetitively over time,” the draft guidance said.