FDA Investigators Finding Fewer Deficiencies For Visual Inspection Programs
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.
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FDA Taking Closer Look at Manufacturers’ Visual Testing Programs While USP Would Set New Limits for Particles
FDA investigators are taking a closer look at parenteral manufacturers’ inspections for visible particles while a proposed USP standard would give more guidance – and much needed clarity – on establishing acceptable quality limits for particles and setting up visual inspection programs.
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