Visual Inspection
This project focused on the implementation and qualification of visual inspection systems for parenteral drug products, including prefilled syringes, vials, and ampoules. The goal was to ensure reliable defect detection—both cosmetic and particulate—while meeting strict GMP and Annex 1 requirements.
QPS Engineering supported the entire process: from defining the inspection strategy and creating defect libraries to qualifying equipment and training operators. Manual (MVI), Semi-Automated (SAVI), and fully Automated Visual Inspection (AVI) systems were all covered.
We provided tailored solutions for each system type, including lighting optimization, camera calibration, and test kit preparation. Operator qualification procedures were also implemented to ensure consistent inspection performance in routine production.
Scope of Services
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Development of GMP-compliant inspection strategies (MVI, SAVI, AVI)
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Design and qualification of reference defect libraries
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IQ/OQ execution of visual inspection systems
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Operator qualification programs and training materials
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System calibration and performance verification
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Audit support and documentation package
