To fight counterfeit drugs, the EU Directive 2011/62/EU demands the introduction of encoded packaging with a unique serial number for prescription drugs. This is to protect both the patient and the pharmaceutical companies. The implementation of this directive is not easy, because most companies must establish a global strategy for the consistent allocation of serial numbers. For this purpose it is essential to adapt advanced packaging processes and to develop new ones for the administration and storage of serial numbers.
Pilot for intergration with Bosch, Advanco and SAP
Integration of the packaging machine is a very important step in every serialization project and needs detailed planning to guarantee integrity and persistent storage of serial data at any time. The connection between the physical machine and machine control software need to be controlled on an enterprise-IT level to have status and data ready at any time. For the connection of packaging machine and enterprise process, a so-called PSE (Plant Serialization Execution) is necessary; a software which translates between machine hardware and the company´s ERP (Enterprise Resource Planning) system and displays the whole production environment.
Integration levels of a serialization project
Bosch, SAP and the SAP partner company Advanco are working on a pilot for the development and implementation of a PSE to offer a seamless integration into the machine level. Here, SAP AII software is used as a basis for the integration. There is only little time left, to amend technologies and processes until the new regulations come into effect. We are at your side, supporting you in facing this challenge.
SAP in pharmaceutical industry
SAP offers mature software to build a counterfeit proof supply chain for the production of pharmaceuticals and also offers a specific consulting solution for this use case.
phone: +49 711 811-57319
Business Development Manager
Track&Trace for Process Industry
SAP Deutschland AG & Co. KG
phone: +49 160 908 23032