The current state of serialization compliance


The latest industry report on "Pharmaceutical Serialization & Traceability 2016" has been published.

The International Quality and Productivity Center (IQPC), has launched its latest industry report. “Pharmaceutical Serialization & Traceability 2016” analyzing the status quo in terms of serialization compliance and the hurdles that still need to be overcome by the pharma industry.

Varying regulatory requirements for pharmaceutical companies

There are currently more than forty different legislations in place that come with varying degrees of detail and complexity as well as deadlines ranging from 2017 to ‘not defined yet’.  There is common consensus that regions with a harmonized regulatory approach, such as the European Union, the US or in the future the Gulf States are easier to cater to when it comes to serialization requirements. Asia is seen by many as the most challenging region as the current and emerging regulations vary greatly.

Different approaches to serialization

The “Pharmaceutical Serialization and Traceability” report looks at four different approaches to serialization compliance

  • Firms opting for a “proactive, aggressive rollout” method of global track and trace programs aim for an agile infrastructure to cater to worldwide regulatory requirements and to futureproof the system for potential regulatory changes or new markets. Around 69% of the report’s participants opted for this strategy to implement serialization across their company.
  • Incremental deployment in a “just in time,” localized approach is another option if your firm chooses to compartmentalize the track and trace process by country.
  • About a quarter of the respondents are « only just getting started » in understanding the regulatory and business requirements, and compliance planning or “haven’t got a formal internal serialization compliance program at all”.

Major concerns for the pharma industry regarding serialization compliance

According to the report, there are multiple points of concern for the industry when thinking of implementing a serialization solution:

  • How can I manage the creation of unique serialization codes for individual products during the production process and how can I coordinate this across all my sites?
  • How can I reach compliance with different legislations on target and seamlessly integrate with third parties including CMOs, 3PLs and CFAs?
  • How about costs related to different coding formats?
  • How can I coordinate serial generation for similar product lines across different sites?
  • Can I efficiently use existing technologies and easily integrate with enterprise systems?

Scary deadlines

Unsurprisingly, deadlines are one of the major concerns when it comes to serialization compliance. Nearly 40% of IQPC report’s respondents expect to need 18-24 months or longer to fully implement serialization which means they will very likely not be ready for the 2017 serialization deadline in the United States. When asked whether the European FMD’s 2019 deadline is enough for the proper testing of serialization, 60% of the respondents agreed but said it’s only just enough and 12% disagreed that it was enough time. However, compared to 30% in 2015, this year, only 25% of companies have advanced little or not at all in their serialization planning strategy.

Read the full report here.


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Jim Cummings is VP Americas at Adents. He has an extensive background in instrumentation, automation and information systems for manufacturing. He also was a founding member and chairman of the Control Systems Integrators Association (CSIA).


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