The Hidden Challenges of Pharmaceutical Serialization

In the almost 40 years since counterfeiting of pharmaceutical products was recognized as a problem by the World Health Organization (WHO), the industry has waged a constant battle against increasingly sophisticated and organized counterfeiters, with drug packaging serving as one of its foremost defenses. The problem varies in severity around the world, but it is a global problem and legislatures around the world are taking action to protect patients.

Serialization is a significant shift in that data will be unique to each pack rather than to each batch. This has huge knock-on effects beyond the installation of new equipment, namely, on the need for increased staff investment and stakeholder engagement. To characterize it as an engineering issue is therefore to grossly underestimate its consequences, which touch virtually every business function in pharmaceutical manufacturing. This white paper looks at the challenges encountered during serialization trials by the ‘early adopters’ and provides guidance on strategies to overcome them. Most trials were undertaken at a time before any legislative imperative or global standards and although these trials have not gone the full extent of serialization and aggregation, the lessons learnt may prove invaluable.