Sound Practices for Consistent Human Visual Inspection

摘要

Numerous presentations and articles on manual inspection of pharmaceutical drug products have been released, since the pioneering articles on inspection by Knapp and associates Knapp and Kushner (J Parenter Drug Assoc 34:14, ); Knapp and Kushner (Bull Parenter Drug Assoc 34:369, ); Knapp and Kushner (J Parenter Sci Technol 35:176, ); Knapp and Kushner (J Parenter Sci Technol 37:170, ). This original work by Knapp and associates provided the industry with a statistical means of evaluating inspection performance. This methodology enabled measurement of individual inspector performance, performance of the entire inspector pool and provided basic suggestions for the conduct of manual inspection. Since that time, numerous subject matter experts (SMEs) have presented additional valuable information for the conduct of manual inspection Borchert et al. (J Parenter Sci Technol 40:212, ); Knapp and Abramson (J Parenter Sci Technol 44:74, ); Shabushnig et al. (); Knapp (); Knapp (); Cherris (); Budd (); Barber and Thomas (); Knapp (); Melchore (); Leversee and Ronald (); Melchore (); Budd (href="#CR8" rid="CR8" class=" bibr popnode">2007); Borchert et al. (href="#CR24" rid="CR24" class=" bibr popnode tag_hotlink tag_tooltip" id="__tag_561477920">1986); Berdovich (href="#CR25" rid="CR25" class=" bibr popnode">2005); Berdovich (href="#CR22" rid="CR22" class=" bibr popnode">2007); Knapp (href="#CR9" rid="CR9" class=" bibr popnode">2007); Leversee and Shabushing (href="#CR23" rid="CR23" class=" bibr popnode">2009); Budd (href="#CR26" rid="CR26" class=" bibr popnode">2009). Despite this abundance of knowledge, neither government regulations nor the multiple compendia provide more than minimal guidance or agreement for the conduct of manual inspection. One has to search the literature for useful information that has been published by SMEs in the field of Inspection. The purpose of this article is to restate the sound principles proclaimed by SMEs with the hope that they serve as a useful guideline to bring greater consistency to the conduct of manual inspection.