How Serialization can Improve Drug Manufacturing Operations

Abstract

An estimated 10% of the global medicine supply chain is counterfeit with sales of counterfeit prescription drugs estimated to be around $75 billion a year. Although estimates about the magnitude of the global counterfeiting problem vary, it is widely recognized that the number of fake drugs being made is growing annually as criminals are increasingly attracted by the high returns and low risks that such activities represent. In 2013, the United States passed the Drug Supply Chain Security Act (DSCSA) requiring Serialization as part of an effort to protect patients from exposure to unsafe drugs that may be counterfeit, stolen, or contaminated. The new law required all prescribed pharmaceutical drug products sold in the U.S. be tracked and identified in every package with a unique identifier that includes essential product information. Although serialization is a compliance requirement, Pharmaceutical companies have embraced the challenge and have taken advantage of the opportunity to automate steps and improve manufacturing operations. Key Terms - Counterfeiting, Improvement, Serialization, Track and Trace.