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September 5, 2025PharmaceuticsOpen Access

Science-Based Risk Assessment for the Categorization of Visual Inspection Defects of Sterile Dosage Forms

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This methodology demonstrates a structured approach for classifying visual inspection defects, implying enhanced quality control in sterile products.

Science-based risk assessment improves defect categorization for sterile dosage forms, enhancing patient safety.
Using a modified Failure Mode and Effects Analysis, this approach categorizes defects into critical, major, or minor levels.
The methodology aids in visual inspections and AQL checks, ensuring defective units are identified and excluded effectively.
Practical applications of the approach were showcased through examples involving vials, pre-filled syringes, and cartridges.

Mahler et al. (2025) studied this question.

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September 5, 2025PharmaceuticsOpen Access

View Full Paper

Ask AI

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Authors

This methodology demonstrates a structured approach for classifying visual inspection defects, implying enhanced quality control in sterile products.

Science-based risk assessment improves defect categorization for sterile dosage forms, enhancing patient safety.
Using a modified Failure Mode and Effects Analysis, this approach categorizes defects into critical, major, or minor levels.
The methodology aids in visual inspections and AQL checks, ensuring defective units are identified and excluded effectively.
Practical applications of the approach were showcased through examples involving vials, pre-filled syringes, and cartridges.

Mahler et al. (2025) studied this question.

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