Visual Inspection mastery is fundamental in parenteral manufacturing in order to guarantee both patient safety and cost-effective supply. The capability of Automated Visual Inspection (AVI) has progressed extensively over the years to the point where, when applied appropriately, it can offer significant advantages over manual and semi-automated inspection processes. This has been made possible thanks to major innovations and technology breakthroughs.
In line with these technological advances, the regulatory requirements for this challenging process have been reinforced. As a consequence, AVI machines today are complex and require multidisciplinary project teams for successful implementation and to manage continuous improvement. This course has been devised to support your AVI program development, by addressing critical parameters, key competencies, and practical approaches to managing the inherent complexity of AVI. After a review of regulatory landscape, key functions of AVI equipment and associated critical parameters will be covered. Then, the participants will look at the interaction between primary packaging component and AVI of the filled drug product. Successful URS development will be covered in order to address not only user needs but also to produce a comprehensive process flow model. Then, the need for an effective Manual Visual Inspection (MVI) baseline process will be overviewed as a prerequisite to AVI. Then, defect kits and validation strategies will be described. AVI has a scope broader than computer vision alone and the overall control strategy for the process will be covered.