It's Go Time! Where is Pharma at with Implementing Serialization?

Over 90 industry professionals recently participated in ISPE’s inaugural 2017 Pharmaceutical Serialization Workshop held at the Sonesta Hotel in Philadelphia, Pennsylvania, USA. With the deadline quickly approaching in the USA and eminent in Europe, there are many efforts that still need to be determined and implemented in the pharmaceutical industry as whole.  Representatives from Johnson & Johnson, Pfizer, Eli Lilly, GlaxoSmithKline, and Sharpe delivered presentations on where their respective companies stand on their journey to be compliant with the various serialization regulations that exist around the world. Learn more about their findings below and where the pharmaceutical industry stands as a whole on the implementation of serialization. Among the companies that presented, the messaging was consistent and apparent from their efforts:

• Serialization is not a packaging project, but a new way of doing business for an entire company.
• There is a significant workforce impact which requires initial and ongoing training.  It may be straightforward to deploy a system, but efforts need to be made to ensure the systems can be operated and, more importantly, managed on an ongoing basis.
• Serialization is only one part of a global anti-counterfeiting strategy.
• When making their facilities serialization ready, multi-site and multi-national companies have the benefit of shifting production to other lines or sites. But there is a burden of deploying a standard serialization system that supports multiple languages and diverse underlying automation equipment - managing regional teams and maintaining a core global team for several years is challenging.

These pharmaceutical companies have been pursuing serialization for several years and their packaging lines are well on their way of being serialization capable.  Since they are somewhat mature in their timeline, focus is beginning to shift to new and/or evolving regulations from around the world, and how the mountains of serialization data can be leveraged within the company beyond compliance purposes – providing visibility of products throughout the supply chain, reducing waste based on product expirations, function in diversion investigations, as well as charge back and rebate processing.  Managing this huge influx of data is a task confronting these organizations and blockchain is being considered for that purpose. There were several significant concerns expressed at the ISPE Serialization Workshop, including meeting regulatory deadlines.  With the United States FDA deadline six months away and the European Falsified Medicines Directive just two years into the future, it is quite clear that manufacturers are nowhere near 100% prepared.  One challenge is how to reach smaller manufacturers and CMO’s that are not ready and haven’t even started serialization efforts.  With a project timeline of 18 months for an initial packaging line and 12 months for each subsequent line, those that have not yet started will not be ready for the FDA deadline in November 2017.  What will become of their products or those companies? A representative from the FDA was specifically asked if the guidance documents the FDA had committed to delivering would be produced this year.  Dr. Connie Jung’s response was “We would really like to.  It’s a handful.”  She cited that they have been “in the works” since the enactment of the law, but the agency has several competing priorities and indicated the FDA is “hoping to get many of those guidances out this year” but couldn’t comment on a specific timeline. ISPE Board Member and Workshop chair Bob Matje implored the audience on behalf of the pharmaceutical industry to provide feedback to ISPE about the next steps pertaining to serialization.  Although ISPE produces guidance documents, and provides training and workshops, these efforts are all member driven. Help us, help you!  What guidance or preparation does your company need to implement for the serialization laws going into effect later this year?  Submit your feedback now.