Serialized Products in Pharmaceutical Industries: Update Strategies through Six Sigma to Decrease the Counterfeit
Date
Authors
Advisor
Publisher
Polytechnic University of Puerto Rico
Item Type
Article
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Abstract
This article discusses the serialization
method established in the packaging lines on a
manufacturing department of a pharmaceutical
plant. It was developed an Installation, Operational
and Performance Qualification to standardize and
ensure the new requirements stablished by Food and
Drug Administration (FDA). This process was
design with the Six Sigma approach, using DMAIC.
This process will allow the pharmaceutical to
enhance the security of their products and comply
with the Drug Supply Chain Security Act (DSCSA).
Key Terms Drug Supply Chain Security Act,
DMAIC, Installation, Operational and Performance
Qualification (IOPQ), Serialization, Supply Chain.
Description
Design Project Article for the Graduate Programs at Polytechnic University of Puerto Rico
Keywords
Citation
Arzuaga Oliveras, M. I. (2018). Serialized products in pharmaceutical industries: update strategies through six sigma to decrease the counterfeit [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.