In the August 2010 issue of Life Science Leader, Gunter Schilpp, Marketing Manager for Mettler Toledo writes a very interesting primer on the application of serialization within the pharmaceutical market.
This piece gives some interesting highlights on the basics of serialization, the minimum implementation requirements, equipment, complexity and regulatory uncertainty involved in pursuing this process.
Mr. Schilpp does an excellent job explaining the various issues and positives of this important evolution of the track and trace solution of supply chain security.
Mr. Schilpp conclusions are that pharmaceutical supply chain serialization should be “considered as an overall strategy of supply chain safety, security, and efficiency.”
Secure Pharma Chain certainly agrees that serialization will become an important component of an overall strategy of supply chain safety but does not believe that there is any one solution or technology that will simply solve supply chain safety and security.
Secure Pharm Chain feels that serialization will be an important tool as part of a larger tool set of solutions that the supply chain uses in defending their inventories and protecting consumers from those intent on tainting the market with fraudulent, adulterated, substandard or counterfeit medications.
Secure Pharma Chain endorses a strategy which incorporates the inclusion of a variety of tools, solutions and technologies, with material authentication as a centerpiece, as the most comprehensive, cost effective and efficient way for the global pharmaceutical supply chain to manage risk and protect both their brand and consumer.
There is no one technology that will solve this problem of supply chain safety and security.
Serialization, like other Track and Trace solutions, follow the transaction from point to point and are important piece of the puzzle, but they require a sophisticated and expensive process that all members of the supply chain must comply with or the chain is broken. Ultimately it does not tell the person handling that product that what is inside the box is authentic and safe.
Authentication, with its ability to verify and authenticate the product and its components at any point in the chain, allows each member of the supply chain the vital assurance of the safety and efficacy of a product from manufacturer to the point of dispense.
Coupled together both tools can protect consumers from those intent on making a profit at the expense of their health.
Knowing where the box has been is important but verifying what is inside the box is vital.
To read the Life Science Leader article, visit:
http://www.lifescienceleader.com/index.php?option=com_jambozine&layout=article&view=page&aid=4091&Itemid=56
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