Handling and Managing of Vial Rejects

Abstract

A large accumulation of filled vial rejects generated in an aseptic filling line of a parenteral medication was identified to be in the custody of the Quality Assurance department indefinitely. Using the DMAIC methodology the current vial handling practices and the batch records from the lots manufactured from 2019 until August 2021 were evaluated. Two (2) root causes were identified for storing all rejected filled vials indefinitely: (1) vials were needed for the visual inspection qualification defect library and (2) no formal procedure was established for the handling and management of rejected vials. New procedures were designed and implemented providing guidance on how to evaluate and onboard rejected filled vials to the defect library, or to discard the vials per waste regulations. The new implemented procedure allows for a compliant, easy to manage vial inventory and it supports the continuous updating of the defect library. Key Terms ⎯ DMAIC, Material Reclassification, Reject Management, Visual Inspection