Serialization – challenges and good practices in packaging operations based on experience of track and trace systems

The introduction of Track and trace (T&T) regulations has driven specific changes to industry packaging practices. Digital information related to the drug has become a major quality-relevant part of the drug packaging process. Unique product identifiers must be applied, verified and transported together with the medicines. Any data discrepancies between the manufacturing and dispensing of the drug will result in the product being suspected a counterfeit and will lead to detailed investigation. This paradigm shift has triggered considerable modifications to drug packaging processes and technologies. While the purpose of most T&T regulations is primarily to fight counterfeiting, additional uses, such as the fight against tax fraud or use for custom controls, introduce additional non-related requirements that often do not follow international standards.

These non-standard requirements influence the technical requirements and established processes in pharmaceutical operations, adding additional complexity and challenges to the implementation and use of serialization on packaging lines. More than ten years after the first introduction of serialization, the pharmaceutical industry still faces a number of technical challenges and limitations relating to regulatory expectations, with many pharmaceutical companies around the world still transforming their packaging operations to meet them.

In response to these challenges, BioPhorum completed an industry benchmark on the serialization of sellable units. The purpose of this benchmark was to identify common industry challenges with serialization and to broaden the knowledge of good practice, industry capabilities and to identify the quickest route to implementation and compliance with global serialization requirements. The benchmark covered the following topics: governance, training, grading of print, overall equipment effectiveness (OEE), decommissioning of serial numbers, technology limitations, primary unit serialization and non-standard requirements.

This paper provides an overview of points to consider and good practices relating to the most challenging areas identified. The four most challenging areas discussed within the scope of this paper are:

  • OEE and system performance
  • Technical limitations
  • Decommissioning of serial numbers
  • Training

This paper seeks to encourage dialogue between industry, regulatory agencies, and T&T system providers, by adding the unique perspective of secondary packaging customer, summarized after several years of using such serialization systems

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