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Serialization and Anti-Tampering for Pharmaceutical Industry

Serialization and Anti-Tampering

The counterfeiting of pharmaceutical products is an enormous risk for consumers’ health and a major economic loss for the pharmaceutical industry. The safety of pharmaceutical products is a necessity for the final consumer and it requires an utmost control of the flow of products, from the manufacturing to the distribution.

In this context, many countries have decided to adopt new regulations with the aim to introduce safety elements for the packaging of medicinal products for human use. This is a significant change that will ensure the authenticity of medicines and safety for patients (and also for the pharmaceutical industry) and will strengthen the security of the supply chain.

One of the components of anti-counterfeiting is the process of identifying every individual packaging which passes under the concept of serialization. Each package - subject to the obligation to integrate the security features - will be coded with a 2D code (GS1 Data Matrix) containing a unique identifier. The data must also be printed in human-readable format and if possible adjacent to the two-dimensional barcode containing the unique identifier.

In addition to the unique identifier, the integrity of the tamper prevention system ensures that the packaging has not been opened or altered after its release from the production facilities, thus ensuring the integrity of the contained drug.

Currently, the needs for serialization are limited to the marking of the unique code on the single product sold. However, from now until 2023, each product must be traceable to the entire supply chain: individual packaging, box / pallet, final distribution point. This level of serialization is called aggregation.

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