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Pharmaceutical Manufacturing and Packing Sourcer

Protection Against Product Piracy

The salesman has finished his presentation of a new, innovative authentication technology, which allows for the differentiation between counterfeit products from genuine ones. As he leaves the room, the discussion starts between the remaining attendants. The verdict is clear: it would be a promising technology for a single location factory; however, in the environment of a globally operating, multi-site group, it would be extremely difficult to implement and operate the system. In order to understand this statement better, I would like to outline the specific requirements of a large pharmaceutical manufacturer against the needs of a small company regarding the implementation of an infrastructure system to fight against product piracy.

DATABASE REQUIREMENTS

Without a specific anti-counterfeiting system in place, authentication is traditionally done by chemical analysis of the suspect sample, and the result is compared to the batch production data. This works fine, but it requires highly skilled personnel using expensive equipment, as well as being timeconsuming and costly. By means of an authentication technology, an easy and instantaneous verification of the genuineness of a product is possible. Such authentication processes should be simple and therefore usable by a layman after little training. In such an authentication process, various properties and data of the primary and secondary package must be checked and verified. To do so, data are required, specifying the status of the genuine product. For example, the authenticating person must know what type of authentication feature has to be present on the inspected package carrying batch X and expiry date Y. To provide such data, a database is required.

This security database has to fulfil a multitude of tasks. As mentioned, its primary objective is to provide information to the authenticator. However, such a database is also an excellent repository for in-depth description of the various parameters of authentication features (for example, the hidden elements of a hologram), drawings and photos as well as training documentations. It allows the management of the life cycle of a security feature, such as tracking the deployment rampup. It also allows the centralisation of relevant data from various production sites and third party manufacturers in one repository, making authentication easy.

As we will see later on, the correct integration of security features is not an easy task. Therefore the first question of the authenticator in case of a missing feature will be: “Has the security technology been applied correctly?” It is also important to recall quality data of the security feature to make a plausibility check of the measured result.

There are not just internal users working with such a security database. In fact, suppliers of security features and packaging materials and even thirdparty packagers will have to access such a data repository from various locations, so internet access is mandatory. Secured access, as well as the management of user profiles and roles can be challenging. This database can be a part of the backbone business enterprise resource planning (ERP) systems such as Systems, Applications and Products (SAP) or a separate infrastructure. Both options provide a viable solution, but the use of an independent infrastructure is more common.


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Sergej Toedtli holds a degree in Mechanical Engineering from the Federal Institute of Technology ETH in Zurich. After an extended career in executive management, he started his company, Vesdo Ltd, in 2000. As a security engineering company, Vesdo focuses exclusively on systems to protect its customers against product piracy. Email: toedtli@vesdo.com
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