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Pharmaceutical Manufacturing and Packing Sourcer

The Highest Level

PMPS: Pharmaceutical manufacturers are obligated to ensure that issued serial numbers across their sites are unique worldwide. How can this be achieved?

Dr Stefan Öing: It is true that the requirements are highly complex, especially given the enormous diversity of serialisation regulations in the international arena. Most companies that operate on more than one site will be compelled to establish a database management system specifically for International Society of Automation Standard 95 (ISA-95) Level 4 standards – in other words, at enterprise level. Solutions for Level 1 (modules), 2 (packaging lines) and 3 (sites) are inadequate for this purpose.

What functions are performed by this system?

In an ideal environment, the system:

  • Takes care of central administration orders and serial numbers
  • Maintains an overview of all logistics, including interim storage facilities and shipping warehouses
  • Can internally pass orders and codes on to the individual works and to external contract manufacturing organisations (CMOs)
  • Communicates with other external service providers, such as carton box manufacturers or printers

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Dr Stefan Öing, head of Atlantic Zeiser’s track and trace software department, specialises in the development of modular software solutions used for serialisation and track and trace applications in the pharma industry. He focuses on solutions that mainly manage and control hardware systems directly, but also enable universal process management up to the enterprise level via comprehensive database applications. Before joining Atlantic Zeiser, Stefan spent many years working as a Product and Project Manager, Head of Development, and Managing Director for renowned companies in the field.
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