Track and Trace Serialization – Pharma Supply Security

Pharmaceutical companies need to keep track of their packages and parcels as they move through the supply chain. Companies need to trace packs at the individual and pallet level so that they can ensure that customers receive the correct products in the right quantity. To do this, pharma supply chains implement a range of security measures, which we describe below.

What is serialization and aggregation?

Serialization is a technique suppliers use to identify products at various pack levels. The process involves ascribing a unique identifier to each parcel at the level required by the individual, company or organization receiving it. (For instance, a wholesaler, hospital or patient).

Products rarely ship solely with pack-level serialization. Aggregation is the process of adding higher-level codes outside packs and pallets that identify end user-level products inside. In some cases, there may be multiple aggregations, depending on the stage of distribution. Aggregation makes it easy for supply chain firms to learn more about the contents of a consignment without having to individually account for each pack.

What is meant by track and trace system?

Track and trace systems are tools that supply chains companies use to determine the location of goods as they move from production to end user. They involve assigning a specific code to each item and then electronically tracking it as it moves. Multiple types of companies use a track and trace system, including those involved in production, logistics, retail and marketing. Increasingly, companies are combining NFC labels with blockchain technology to ensure more robust track trace systems.

What is serialization in pharma?

In the global pharmaceutical sector, serialization is the process of ascribing unique identifications to each pack of pharmaceutical goods as it reaches the end-user. Importantly, global serialization doesn’t just track the type of goods being shipped, but the individual entity. So, for instance, when shipping a consignment of vaccines, each box of medication would have a different identification product code to differentiate it from every other box. Thanks to Authena technology, it is possible to track, trace a package from manufacturing to when the product is opened by the consumer. Solutions allow for drug traceability at multiple stages of delivery.

What is track and trace in the pharmaceutical industry?

Track and trace is a system that applies to all industries – not just pharma. The idea is to monitor the journey of products from their source (usually a manufacturer’s factory) to their destination (typically a clinic, retailer or customers in the pharmaceutical industry).

For electronic track and trace to work, companies throughout the supply chains must upload data to a central system shared by all. Companies should provide distributor, production, location and unit details.

Since laws for track and trace vary by region, most companies that ship internationally provide the maximum amount of information possible to avoid regulatory hurdles. Additional requirements beyond the basics could include things such as serial number format, the way companies in the supply chain aggregate shipments, and guidelines for primary and secondary packaging.

Track and trace is different from serialization. In serialization, products receive a unique serial number assigned to each sealed entity. In electronic track and trace, pharma companies use pack data to monitor the location of shipments as they move through the supply chain.

Why serialize products?

Secure delivery of goods

There are many advantages to serializing products. Perhaps the biggest benefit is the ability for operators in the supply chain to trace products at both the product and unit levels. Previously, suppliers tracked and traced at the generic level. However, in many industries, pharma in particular, tracking at the pack level allows companies to monitor each individual consignment. It also makes it easier to flag any product quality issues and return missing packs to larger batches.

Counterfeit drugs and serialization

Serialization also improves suppliers’ ability to detect counterfeiting. Malicious actors in the supply chain could attempt to swap out certain goods for inferior products anywhere between the production stage and delivery to the end user. By adding an extra layer of security, serialization allows agents in the supply chain to account for every last box. Provided traceability is an effective way to eliminate counterfeit drugs.

Comply with regulations

Lastly, serialization is critical for enabling pharma companies to comply with regulations. Many countries are increasing the stringency with which they oversee the pharma supply chain in an attempt to improve traceability and patient security. Having serialization and track and trace in place, therefore, making it substantially easier for companies to comply with the law.

What does the law in the EU and US say about serialization?

In the USA, the requirements for serialization of products are stated in the DSCSA under Title II of the Public Law 113-54. Major stipulations involve rules for product identifiers (including a code that contains a unique ID for each product, batch number, and expiry) and product tracing, allowing companies to see electronically where their shipments are in the supply chain at any given time.

In the EU, aggregation is not a requirement of the bloc’s Falsified Medicines Directive (FMD). However, all pharma products must have a unique identifier when passing through the region. All pharmaceutical manufacturers must upload the information to the European Medicines Verification System and follow packs as they make their way through various stages of the distribution chain. Technically, firms can achieve this without aggregation, but that is not recommended.

How to serialize products?

Serialized products require linking package-level and aggregate information to the company’s digital tracking software. Usually, this requires setting up a “parent and child” system, where the parent is the aggregation-level packaging and labelling, and the child level is the individual pack level information.

Having an IT-connected system allows brands to monitor the location of parcels at any point in time. Software like this provides serialization management capabilities.

Serialized products require the development of a system that allows pharma brands to track shipments at various levels of aggregation.

Pallet-level serialization allows tracking and tracing operations at the level of the logistics center or wholesaler. Codes on the outside of pallets allow these operators to move large shipments of goods to their desired location rapidly.

Serialization for track and trace can also require putting information at the multi-pack level. This level of aggregation is helpful for operations at the distribution center level (particularly in situations in which end-users do not require entire pallets).

Serialization at the individual packaging level allows hospitals and clinics to trace individual shipments. And, lastly, tracing at the vial level makes it possible to follow the whereabouts of individual doses of drugs (which is helpful at the patient level).

How can Authena’s solutions support serialization in your business?

Through its end-to-end technology framework, Authena is able to provide serialization and aggregation services for your pharmaceutical business. Thanks to the use of NFC technologies it is able to serialize, trace and track back products until the minimal sale unit, providing each of them with a digital blockchain-passport certifying origin, integrity, and authenticity. In addition, through the development of revolutionary IoT wireless devices Authena technology can even monitor real-time location and environmental conditions of single medicines.