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Coating Process Improvement
(Polytechnic University of Puerto Rico, 2021)
An increase in the number of events associated to AQLfailure that resulted on partial batch rejections was observed in 2020 for Tablets/Caplets formulations due to cosmetic conditions ...
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 ...