Automated visual inspection (AVI) in sterile injectables is often managed through reject rates, throughput, false rejects, and line efficiency. However, regulators view AVI as part of product disposition. Therefore, reject handling is a GMP record system, not simply a production activity.
A compliant process must show what was rejected, why it was rejected, who confirmed the decision, how it was documented, and how the result affected trending, investigation, CAPA, or batch release. FDA expectations also cover investigation, corrective action, and documentation of rejected units.
In this case, our team assessed AVI reject governance and defined practical actions to strengthen procedures, documentation, QA review, and batch defensibility.
Disconnected QA Review: Missing QA review can weaken the link between reject data and batch disposition.
Uncontrolled Re-Inspection: Re-inspection needs authorization, justification, documentation, and preserved original results.
We work with pharmaceutical teams to design, implement, and run effective Quality Management Systems, covering change control, CAPA, deviations, and audits to support consistent GMP compliance.
The SOP should control reject definitions, responsibilities, segregation, confirmation, categorization, documentation, disposition, escalation, re-inspection, deviation triggers, and relevant changes.
QA should verify that AVI reject records are complete, traceable to the batch, and consistent with the inspection summary. The review should confirm that deviation triggers were assessed, required deviations were opened, original reject outcomes were preserved, and the final disposition rationale was documented before batch approval.
