Intentionally Created vs In-House Visual Inspection Defect Kits
In the highly regulated world of parenteral drug manufacturing, visual inspection serves as a critical quality control step to ensure that injectable products are free from visible particulate matter and container defects. The US FDA, EMA, PMDA (Japan), TGA (Australia), and other regulators have consistently stressed the need for robust, scientifically justified, and well-documented visual inspection programs.
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