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Handling and Managing of Vial Rejects
(Polytechnic University of Puerto Rico, 2021)
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 ...
Strategy for the Reduction of False Rejects in the Visual Inspection of Injectable Drug Products
(Polytechnic University of Puerto Rico, 2022)
A hundred percent visual inspection is performed as part of the manufacturing process of injectable drug products as a regulatory
requirement to detect and remove units with defects to protect the patients. The rejection ...