Reliability of Operators performing the Visual Inspection of Parenteral Drug Products

Abstract

The visual inspection of parenteral product filled vials is performed to assure that any damaged or defective unit is detected and removed prior to packaging. This investigation evaluated the visual inspection process of parenteral products with manual handling to enhance actual process and reduce regulatory exposure. It challenged the probabilistic inspection results due to variability within operators and inspection time. A total of three (3) different standard sets of 100 vials each were evaluated by three (3) inspectors of high, medium and low experience level. The study concluded with a 95% confidence level that there is no significant difference between the results obtained at forty (40) and fifty (50) seconds inspection time neither between the interaction of inspectors and inspection time but that there is significant difference between operators. Consequently, initial and continuous training are essential elements for the quality assurance of the visual inspection process. Key Terms – analysis of variance, operators reliability, parenteral products, visual inspection