Serialization – An Effective Solution to Prevent Counterfeits

Ensuring the authenticity and integrity of medications throughout the supply chain remains a significant challenge for the pharmaceutical industry. Each year, regulatory agencies and pharmaceutical companies spend billions of dollars to recall counterfeit or expired drugs. Serialization has emerged as an effective solution to this issue.

In simple terms, serialization is the process of assigning a unique code to each saleable unit. This process ensures the authenticity and safety of medications by allowing regulators to trace drugs and identify their origin in case of any incidents.

Serialization enables pharmaceutical manufacturers to achieve the following objectives:

• Anti-counterfeiting: Assigning a unique code to each saleable unit makes it more difficult to counterfeit drugs.
• Product recall: In the event of a safety issue, regulatory authorities can use serialization codes to quickly and efficiently identify and recall affected drug batches.
• Supply chain tracking: Serialization enables the tracking of drugs as they move through the supply chain, from manufacturer to retailer and ultimately to the consumer. This helps identify potential issues in the supply chain and ensures that drugs are handled properly.

Under Directive 2011/62/EU, all prescription drugs in Europe must be serialized. Since 2019, non-compliance with serialization requirements means that ETC pharmaceutical products cannot be sold in the European market. In the future, serialization will be extended to OTC products in Europe.

From the smallest unit, such as blister packs, to bottles, cartons, and pallets, each can carry a unique identifier. This identifier may be a QR code or DataMatrix code (depending on the country/region) and contains information about the product’s origin and authenticity.

These codes are printed directly and clearly on the respective packaging and are linked to one another. For example, the code of a bottle is linked to the code of the carton it is packaged in, and this code is further linked to the pallet transporting it from the factory/warehouse.

1. Pharma Serialization Definition

Pharma Serialization involves assigning a unique code to each saleable unit of medication and printing this code on the packaging. Two key concepts in this context are pharmaceutical packaging and the “unique code.”

1.1. Pharmaceutical Packaging.

• Primary packaging: This is packaging that comes into direct contact with the drug. Aluminum blister packs are the most commonly used primary packaging.  Serialization on primary packaging is not mandatory outside the US and Indian markets.
• Secondary packaging: This packaging contains the primary-packaged medication. Carton boxes are the most common secondary packaging. Serialization on this packaging is mandatory to meet regulatory compliance. Some regulations, such as the EU Falsified Medicines Directive (EU-FMD), require tamper evidence on packaging along with serialized code, to ensure that patients are the first to open the medication.

• Tertiary packaging: Tertiary packaging enables B2B transactions in the supply chain by consolidating the medication into bulk units. Common examples of tertiary packaging include sacks or pallets. Serialization at the tertiary packaging level is essential for ensuring traceability across the supply chain.

1.2. Structure of Serialized data

The definition and structure of serialized data are determined by country-specific regulations, though most follow tiêu chuẩn GS1.

According to the EU-FMD, serialized data must be performed on the primary packaging or saleable packaging in Europe. To verify data, manufacturers must serialize product data and send the serialized data to a central repository for query purposes.

To serialize, verify, and report to regulatory bodies, the EU-FMD mandates that manufacturers mark packages with four data elements, which must be printed in human-readable form, encoded, and stored in a GS1 2D DataMatrix:

• Product Identifier (GTIN – the global trade item number): Used to verify a product at any packaging level (saleable unit, carton, or pallet). This information provides a universal language to uniquely identify an item worldwide for all relevant entities and trade partners;
• Serial number: A numeric or alphanumeric sequence of up to 20 characters, unique to each GTIN;
• Batch number: A company-specific code that allows identification of product batch information;
• Product expiration date.

2. Serialization and Aggregation

While Serialization involves assigning a unique code (serial number) to each saleable unit of medication and printing this code on the packaging with detailed information about the medication, such as manufacturer, batch number, expiration date, and active ingredients, aggregation links serialized units into larger groups, such as boxes, cartons, or pallets.

Comparison of Serialization and Aggregation:

Example:

• During production, each saleable unit is assigned a unique serialized code.
• Each saleable unit is then aggregated with other similar units to create a shipment.
• The shipment’s aggregation code is linked to the serialized codes of all units within.
• When the shipment is transported, information on the aggregation and serialized codes of each unit is tracked to ensure product authenticity and safety.

Stay tuned with SEN Pharma for the next part of our series on Serialization.

If you’re looking for an optimized serialization system installation, don’t hesitate to contact SEN Pharma at 086 918 0917 for fast and expert advice !

References

1. A Non-Fungible Token Solution for the Track and Trace of Pharmaceutical Supply Chain
2. Tamper-proof Closure Seals
3. Pharma Serialization – The Most Comprehensive Description