Pharmaceutical contract manufacturer

How did a contract manufacturer supply 1,000,000 serialized packages for multiple pharmaceutical customers with varying standards and procedures… and within a network of multiple production sites, contract manufacturers, re-packers and other service providers – and all according to the expected EU regulations to centrally register all the unique codes?

Traceability through serialization

Reduce counterfeiting – increase consumer information

The ability to trace individual products through the supply chain is becoming increasingly important to fight counterfeiting and increase consumer safety. This applies to the pharmaceutical, cosmetic, tobacco as well as to the food & beverage industries.

While traditional lot and batch level traceability provides a level of supply chain risk management, serialization provides item-level traceability. This means individual items can be traced from manufacture, right through distribution and retail to end consumer use.  Among the many benefits this includes ensuring individual items are authentic and whether they have been distributed via legitimate channels.

There are two main challenges to achieve a comprehensive traceability through serialization solution:

  1. Managing the data internally, with supply chain partners, and with the consumer oriented servers
  2. Changing the production hardware and processes.

To meet these challenges two main ‘philosophies’ have arisen to deal with the new data management and production process demands –  the single-system point-to-point (closed single supplier) solution or the flexible ‘layer’ solution. By separating data handling from the production line, the flexible layer solution brings numerous systems benefits.

 

Applying a serialized code within the production line seems like a relatively easy task, especially since various commercial solutions are available in the market. However, with the need to register these codes within a central server, a new challenge arises for pharmaceutical companies: to set up an additional, secure and error-free data handling and communication process.

And with a network of production sites, contract manufacturers, re-packers and other service manufacturers, the intra-network communication may become a hugely formidable additional
challenge, especially in a market environment where no standards are defined and frequent changes and updates are expected.

When Hans-Peter Supik evaluated existing serialization solutions just over a year ago, he quickly realized that these would not fulfill all his requirements and would not be flexible enough in the current environment. “We then looked in our local network and contacted REA Printing, whom we knew to be very knowledgeable in printing serialized codes. REA recommended the Omron inspection solution as the most flexible and easiest to integrate,” said Hans-Peter Supik. “Today with the experience of over 1 million packages serialized, I am very happy with my choice.”

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