Pharma Serialization Strategies

What is Product Serialization?

Refers to the assignment and placement of unique serial number on a primary package (e.g. Bottle). These markings can be a uniquely serialized 2D bar code, a human-readable code or an RFID tag. These unique codes are placed on each primary package (item), case and pallet then read by a vision system on packaging lines. These unique codes are uploaded to a database that can be accessed by various parties, including pharmacists, law enforcement officials and even consumers after the product is shipped and sold.

  • Value of Implementing Serialization
  • Improved patient safety from dispensing errors
  • Detect and eliminate product counterfeiting
  • Achieve more accurate order fulfillment and shipping
  • Achieve greater inventory visibility
  • Improve the effectiveness and compliance of recall process
  • Improve Returns Materials Authorization (RMA) process
  • Access to more timely and accurate downstream data

What is Pedigree/e-Pedigree?

A paper or electronic document (e-pedigree) that enables a single view of the product, order and shipment including identification. Used for drug authentication by stakeholders, the pedigree goes with the drug and tracks the change of custody as the drug passes through the supply chain.

Looking at (and understanding) all of the items required for compliance can seem endless.

The best plan for success is one that clearly defines all of the required pieces.

  • Prepare for worldwide serialization strategies
  • Pedigree at the smallest unit made by manufacturer for sale to pharmacy
  • Leverage proven technology
  • Adhere to deadlines in the markets you serve
  • Use a “Trusted” Supply Chain