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FDA Investigators Finding Fewer Deficiencies For Visual Inspection Programs

 
• By Joanne S. Eglovitch

Experts on visual inspection and patient risk attribute a downward trend in inadequate visual inspection plans for particles to a new USP chapter that offers greater clarity on testing conditions. While there is negligible safety risk posed by visible particles, manufacturers should still conduct particle characterization studies. And no, glass particles are not risker than metal or wood particles.

Greater clarity on visual inspection programs for parenteral drugs covered by the US Pharmacopeia’s new Chapter <790> may be the reason why FDA investigators have been finding fewer problems in this area over the past few years, industry officials said. Yet new observations are cropping up for inadequate sampling plans for visual inspections.

The new chapter, called “Visible Particulates in Injection,” clarifies testing conditions and sets acceptable and unacceptable quality limits for particles, John Shabushnig, principal consultant with Insight Pharma Consulting, said Sept....

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• By Derrick Gingery

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