Strategy for the Reduction of False Rejects in the Visual Inspection of Injectable Drug Products

Abstract

A hundred percent visual inspection is performed as part of the manufacturing process of injectable drug products as a regulatory requirement to detect and remove units with defects to protect the patients. The rejection of acceptable drug products in the visual inspection process increases waste and manufacturing costs. The analysis of historical data identified three vial defect types with a trend of high false reject rates. A second inspection step method with reference standards was designed as a strategy to reduce false rejects in the visual inspection process. The experimental results obtained showed a significant reduction in false rejects during the visual inspection process. The reduction of false rejects translates into fewer financial losses as waste for the organization. Key Terms ⎯ False Rejects, Improvement, Pharmaceutical Industry, Visual Inspection.