Cosmetic Defects in Parenteral Products: More Than Just Appearance

While cosmetic defects like scratches, air bubbles, or minor glass imperfections may not compromise sterility or efficacy, they can still trigger batch rejection or regulatory scrutiny. In parenteral manufacturing, visual inspection must distinguish between critical, major, and minor defects ensuring patient safety without over-penalizing aesthetic flaws. A robust qualification process for inspectors and test sets is key to maintaining this balance.

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