Serialization

ISPE Annual Meeting Wrap-Up

The Adents Team Written by The Adents Team
13-Nov-2018

At the recent ISPE Annual Meeting which was held November 4 – 7, 2018 at the Pennsylvania Convention Center in Philadelphia, PA, we attended the End-to-End Supply Chain Management track on Day 2 of the conference where the focus was on Sustainable Serialization Solutions.

Panel members included Anders Brummerstedt, CPIP, Sr Project Manager and Advisor/Specialist, PEC, Alf Penfold, MBA, Sr. Project Manager and Advisor/Specialist, PEC and Elizabeth Weaver, Technical Subject Matter Expert, Serialization, Clarke Solutions.

Some of the topics discussed included managing large and complex programs, global serialization timelines, and how to deploy and maintain a sustainable serialization solution.  Expert panel members offered insight to the specific subject matter based on their industry experience, the session was very well attended, and the Q&A portion touched on some of the issues experienced in implementation.

As in any project, good project management methodology is very important in any serialization initiative. Some of the areas of emphasis:

  • Executive buy-in is extremely important to ensure project commitment.
  • Inclusion of all affected stakeholders allows voices to be heard and all needs met.
  • Good definition of goals and requirements ensures the solution effectiveness.
  • Good testing ensures solution compliance with requirements.
  • Training of personnel is very important to ensure solution usefulness.

Despite the efforts of GS1 and others, there is no overall standardization of country regulations which makes it difficult for solution providers to handle all scenarios.

Additionally, countries continue to rethink their decisions and make changes to regulations, with China and Brazil as examples. Compliance dates for each country vary and there are several countries looking at the experiences of early adopters for direction and in some cases implementing similar requirements. In order for a solution provider to meet the different regulations and to deal with the evolution of new and changing regulations the solution needs to be powerful, flexible and very efficient.

The serialization project is not one that is completed and left as is at the end of validation and training. The solution will require updates and additions as hardware, software, and country regulations change. Some of these include:

  • Hardware obsolescence. At some point there will be a need to replace the computer hardware. Will exact or similar options be available?
  • Operating system obsolescence. Microsoft brings to the market new operation systems on a regular basis. Will the serialization software operate on the new OS?
  • As indicated in the country regulation presentation, new regulations may be added and there may be changes to existing regulations.
  • New products may be added.   
  • New equipment such as a bundler may be added to the packaging line.

If you look at the summary of the panel discussion, the message is to get the right team, define the needs, select a solution that meets today’s and tomorrow’s needs, and most importantly, implement with the correct methodology. Early serialization adopters have learned that they installed solutions that were available at the time, but now see these solutions are not capable of dealing with change or costing great amounts to change. It is extremely important to look for a serialization solution that minimizes implementation time, maximizes line and operator productivity, and reduces validation efforts and change management.   

The Adents Team
The Adents Team

The Adents Team: your serialization experts. With over 25 years of experience in different fields of product traceability, supply chain, big data and pharmaceutical serialization, our team members bring a wealth of knowledge to help you better understand the challenges and opportunities of serialization.

DISCOVER MORE ...

Pharma Track & Trace Requirements in Russia Decrypted
Pharma Track & Trace Requirements in Russia Decrypted
Managed by the CRPT, the Crypto verification is the one of the main ingredients of the drug track & trace requirements in Russia.
Drug Serialization Requirements in China: New Guidance Documents
Drug Serialization Requirements in China: New Guidance Documents
NPMA publishes new guidance documents for 2022 serialization compliance.