Serialized Products in Pharmaceutical Industries: Update Strategies through Six Sigma to Decrease the Counterfeit

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.