The two things you need to do before starting on a serialization journey

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The pharmaceutical industry has undergone a dramatic transformation in recent years; mergers, acquisitions and the emergence of complex manufacturing networks have all added complexity in manufacturing operations with multiple manufacturing sites sprawled across regions and across the globe. We’ve already discussed the benefits of serialization, but it’s not enough to implement a solution in one plant. Deploying a standardized serialization solution across multiple sites to leverage economies of scale and standardize operations seems a reasonable way forward. However,  where do we start?

In my previous blog on the key questions to ask in order to map out a well thought-out implementation plan, I pointed out some of the key features to look for as you begin your serialization journey:

  • Compliance and Flexibility: Ability to meet current country regulations and flexible to updates to meet future mandates
  • Software Compatibility: Ability to integrate with existing operations systems
  • Hardware Compatibility: Hardware agnostic and able to work with cameras, high speed printers and thermal label printers
  • Functionality: Multiple levels of aggregation and able to detect rejected child unit at parent level

To find the right serialization solution meeting the above-mentioned challenges, there are two essential things you need to do – establish a core team and run a pilot project.

The core team

Serialization involves multiple overlapping functions; no single department or individual is wholly responsible. Therefore, the core serialization team will be necessarily cross functional and identifying and recruiting employees from the relevant departments is paramount. Team composition will vary from organization to organization, but a sample team could include representatives from the following departments:

  • Quality and Compliance
  • Information Technology
  • Packaging
  • Production Operations
  • Supply Chain Management (includes sourcing, distribution and warehousing)
  • Regulatory Affairs / Legal

With your core team in place, the next step is evaluating and engaging a partner who has deep expertise in serialization. The partner will be able to advise you on the serialization solution that is most appropriate for your plant requirements.

Run a pilot project

Once you’ve identified a solution with your core team, running a pilot test project on a line with aggregated packaging stations and palletization station will help to identify any issues before a large-scale multisite deployment. In addition to the operational features of the solution, also consider these requirements from a company-wide perspective:

  • Standardization: Ability to fully integrate across multiple sites, including support for the many “standards” in place in those plants (PLC’s Cameras, Printers to name a few)
  • Full Track and Trace Capability: Ability to link up with supply chain management and traceability system beyond the plant floor for full track and trace capability
  • Workforce Changes: Imposing the least impact on employees working in the newly regulated environment

Beginning your serialization journey is never easy; a trusted partner who can help to establish best practices will go a long way.

Are you considering implementing serialization? Let us know your thoughts in the comments!

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