Serialization Basics

Hello good people of the world! Today’s post is high-level regarding serialization. Serialization is a process mandated by the world’s regulatory agencies to reduce counterfeit drug products in the market. Besides being costly to drug companies, counterfeit drug products are often less efficacious and less safe than the real drug they are purporting to be. Additionally, counterfeit drug products can be contaminated with other APIs and/or toxic excipients.

In the United States, regulations were passed in the year 2013 to require drug manufacturers to have serialization in place by November 2017. In response to industry struggles, the agency delayed enforcement until November 2018. There has been no further extension, meaning the deadline is coming fast (as of the time of this writing).

Specially, all drugs manufactured in the US should be serialized by November 27, 2018 or face regulatory action.

What does serialization actually mean? The overall concept is that any finished drug product on the market (e.g. vial, packet of tablets, etc.) should be traceable back through the supply chain to the manufacturer to verify the authenticity of the product. Each unit (vial, packet, etc.) would have a unique serialization number, and there would exist an interface where an end-user could verify the serialization number is real, confirming the authenticity of the product.

In reality this means drug manufacturers must have software that:

  1. Generates unique serial numbers
  2. Applies serial numbers to labels
  3. Tracks when serial numbers are applied and/or destroyed
  4. Creates a repository of serial numbers that end-users can query against

Of course there are many nuanced details to consider (e.g. how to handle aggregation), but those are some high-level concepts.

Are you ready for the serialization deadline? Comment below.

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One thought on “Serialization Basics”

  1. Hi Mike,
    very good post covering serialization in a very clear and crispy post. Thanks a lot.
    is it possible for you to provide an overview on timeline set by different regulatory agency/country and minimum expectations?

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