Highlights of the presentation

 

FDA event page: Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act.

 

Solution Provider Perspective

  • 15 000 packaging lines needs serialization globally within the next 5 years
  • 25% completed

“Not an easy task”

Line Level

  • Every line is different and already exists…
  • Serialization and Aggregation solutions must adapt with existing equipment
  • Every line implementation requires engineering

IT Level

  • No standard between the line, plant and corporate levels
  • Optel Vision is a founding member of Open-SCS Workgroup
  • Open-SCS (Serialization Communication Standard) will allow the industry to implement faster and cheaper

Our views on the industry

  • We are continuously increasing our capacity to support an increasing demand
  • Our competitors are all facing the same challenge
  • Some competitor did not grow and their lead time is now 1 year
  • 2017 is coming quickly and even though most manufacturers are taking the deadline seriously, some will have difficulty to be ready on time.

Aggregation

  • More than 2 times more complex
  • Lead time for aggregation projects is twice than serialization-only projects
  • 50% of manufacturer opt to do a single phase (with aggregation)
         Because they feel it is needed sooner than 2023
         Because they are saving up to 30% when doing both at once
  • A lot of confusion on whether or not it is necessary for 2019 (Verification requirement for Distributor)

Recommendations

  • FDA must give a clear message on when Aggregation is required
  • If Aggregation comes before 2023, then FDA should wait at least one year prior to enforce the Nov 2017 requirements

 

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