Extraneous Matter Specification

Extraneous matter specification establishes acceptable limits for foreign objects including glass, metal, and fibre contamination within pharmaceutical products. Visual inspection identifies visible contamination. Mechanical sieving removes particles above specified sizes. Metal detection systems identify ferrous contaminants. Regulatory specifications establish zero acceptable levels for certain contaminant types.

Manufacturing environment controls minimise extraneous matter generation. Equipment inspection prevents debris shedding. Container-closure materials require validation confirming integrity. Regulatory inspections assess manufacturing practices preventing contamination. Recall procedures address discovered contaminated products protecting patient safety.