Serialization Pharma: Meeting the Global Serialization Requirements

WIPOTEC-OCS is very well positioned globally. With more than 100 branch offices and partner companies, we are very close to pharmaceutical customers and CMOs (Contract Manufacturing Organizations) on the sales and service side. Thanks to our broad Serialization & Aggregation portfolio, many doors open up to us worldwide, benefitting not least our customers.

We concentrate here on participating in working groups of the VDMA (Protect-ing) and on our status as a solution partner for GS1 Germany. Together with GS1, we work out solutions for implementing pharma serialization and aggregation smoothly and in compliance with regulations. Our international activities also provide our customers with additional benefits. These are, for example, our active participation in the GS1 Global Healthcare User Group and our founding membership of the steering committee in the Open-SCS Working Group. Our active participation in a large number of national and international associations and groups means that we are always on the ball and able to pass on the latest developments and findings regarding serialization and aggregation in the pharmaceutical industry to our customers.

The serialization of pharmaceuticals is highly strategic and is assigned a key role in the production environment. It ultimately depends on this whether a product is saleable at all. A completely controlled production flow can still fail right up to the last stage in the product design process, possibly the palletizing of individual boxes prior to shipping.

Since February 2019, pharmaceutical companies in the EU have had to serialize their products in accordance with the EU Directive. They therefore had less than two years to implement a serialization solution. For the US market, the deadline was set for November 2018 – American pharmaceutical companies had to comply with the requirements of the DSCSA guidelines by then.

This is where best practice from WIPOTEC-OCS comes into play. We provide standardised serialization machines which perform the greatest possible number of required market- and manufacturer-specific functions. Pre-engineering thus enables a lead time of six weeks. The delivery and configuration of an open XML interface which is included in all Serialization & Aggregation (i.e. Track & Trace) TQS solutions allows serialization machines to be installed and commissioned in the shortest time possible. The solutions from WIPOTEC-OCS are perfectly tailored to meet the needs of pharmaceutical companies, enabling them to achieve timely compliance with guidelines on the serialization obligation. As a result, there is hardly any faster way to meet the international requirements for serialization in the pharmaceutical industry while at the same time avoiding proprietary stand-alone solutions.

TQS Fast Track- the fast response to tight serialization deadlines

To the serialization pharma solution

So along with the open system interface, it is not only the very short delivery times for best practice serialization and aggregation machines or the options for universal integration into other packaging machines which are the key benefits of the complete Serialization & Aggregation (i.e.Track & Trace) solutions from WIPOTEC-OCS. The fact that the overall system originates from a single source, is built in a single location and is controlled via a single interface is at least equally important. In addition to serialization parameters, it is possible to detect other product attributes such as weight and code quality for a truly unique selling point. All attributes can be stored together with the serial number (TQS Traceability+).

Outstanding features of Track & Trace TQS: Free software updates

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