Serialisation in the pharmaceutical industry is a necessity, but many perceive it as a compliance measure. This attitude is impeding pharmaceutical companies from leveraging significant opportunities. It is vital to understand that compliance is not just reporting.

Everything from packaging, to sales, to exports, and returns are a part of the ongoing business process. Pharma companies need to understand that Serialisation is an important business process that must be followed to ensure greater operational efficiency and higher profit margins. Having said this, let’s dive deeper into the topic to understand the basics of Serialisation and its importance.




Serialisation is assigning a unique serial number to every saleable unit, to be able to track them through the entire supply chain, from production until it reaches the end user.

E.g.: As per the Drug Quality and Security Act (DQSA) regulation, it is mandatory for all prescription drugs in the US to have Serialisation at the saleable unit and case level.

The government and/or trading partner provides Serialisation numbers to licensed manufacturers, which need to be downloaded securely from the government agency’s server. Similarly, the batch process data needs to be uploaded to the same server. It must also include the secure decommissioning of rejected or unused Serialisation data.



As discussed earlier, product Serialisation is the process of assigning a unique identity to each item in the form of QC code, RFID, NFC, etc. When the product is serialized, it can easily be tracked with the help of the code.

Many countries have made product serialisation mandatory for pharmaceutical companies. With offshore manufacturing becoming more acceptable and common, most products are exported and imported globally, which makes supply chain visibility challenging for manufacturers. In addition to bolstering supply chain visibility, Serialisation digitalizes the entire process, which results in repeat sales and better consumer retention.




The process of serialisation varies on the requirements set down in country-specific regulations.

If we are talking about US then, the FDA recommends using Standard Numerical Identifiers (SNIs). Pharmaceutical industries use a Serialized National Drug Code (SNDC), which is a combination of NDC and unique serial numbers. The codes in Serialisation can be generated sequentially or randomly by the client or the manufacturer. Once the serialisation number is procured, the manufacturer will put a 2D barcode on every saleable unit and shipping case.

When ready for packaging, every label is scanned to determine the proper placement of every unit in each case.



In most cases, GS1 organization guidelines that specialize in traceability are used to prepare serialisation regulations for the pharma industry. The Serialisation process is complete only after the code is printed on the packaging of the drug. Here’s some information you need to implement serialisation in pharmaceuticals:

Global Location Number (GLN) and Global Trade Item Numbers (GTIN)

GLN and GTIN numbers are easily available if you register with the local GS1 organization in your country. The GLN is the global address from which a pharma company operates, and the GTIN identifies products and services.

Serial Number

A serial number is a numeric or alphanumeric character sequence that can have up to 20 digits. There is a unique serial number for every GTIN.

Expiration Date

The expiry date of the drug.

Lot Information

This is the company-specific production information used during the manufacturing of the drug.



Serialisation is the solution to many problems being faced by the supply chain process globally. Let’s look at the two main reasons:

  • Current processes are labor-intensive. As a result, the end buyer has to pay a higher price for the drugs.
  • A product changes hands at least 10 times, from the manufacturing stage to when it reaches the consumer.

All these factors make it imperative to implement Serialisation at different levels.


Other Benefits of Serialisation

Here are some of the reasons why serialisation is necessary for the pharmaceutical industry. 


In addition to improving the supply chain, serialisation has helped to tackle counterfeit medicines. Duplicate and counterfeit medicines are raising issues with pharmaceutical companies at the global level. Manufacturers often find it difficult to stop production at a counterfeit manufacturing facility, as the medicines are manufactured in different stages and locations, and these locations can even be in different countries.

A survey by the World Health Organization revealed that almost 50% of the drugs sold on the Internet are counterfeit, and around 90% of the drugs sold are not originally from the country listed on the website.

This is where serialisation can be of great help. A comprehensive system is set up to track and trace the transit of prescription drugs. It can help identify every entity, with the help of a unique serial number. Also, it is possible to verify information such as the origin country, shelf life, and the batch number of the entity. This way, the entire life cycle of the product, right from its production, to its distribution, until it reaches the end user, is present in the database.


There’s no doubt that serialisation simplifies the business process, but it comes with a few challenges. Let’s look at the major ones:


Serialisation could mean a major change in label design for many manufacturers, to have more space for the 2D barcode. This, at times, leads to a redesigning of the graphic elements, packaging structure, etc., resulting in additional expenditure.


Pharma companies need to expand their data management and IT architecture to leverage the benefits of Serialisation. The IT department must be agile and sound enough to generate, capture, store, and transmit hundreds of thousands of serial numbers for different supply chains.


Scanning bundles and labeling every pack will slow down the packaging process. This makes it necessary for the manufacturer to automate the process, or increase manpower, to ensure production efficiency doesn’t suffer.


Introducing serialisation means updating equipment, software, and hardware, training team members, and adding more talent. All this additional cost can drive up the costs in a pharma company’s budget.


Irrespective of the challenges, pharma companies are adopting serialisation. Blame the mandatory guidelines or the need to become more efficient, Serialisation is becoming the cornerstone for the success of pharma companies. When executed the right way, it helps make the supply chain more transparent. At the micro level, serialisation proves to be effective against theft, counterfeiting, and diversions. Being able to trace the live location of the product also makes it easy to keep an eye on the shipment, and remove defective or recalled products, if required.


Switching to serialisation comes with its own set of expenses and changes. Here are some of the factors that will require your attention when you implement Serialisation to improve the supply chain:


Before implementing serialisation, pharmaceutical companies need to allocate a budget to upgrade their equipment, software, and hardware to apply for serial numbers and manage the data procured during the process. 


Do you have enough resources and manpower to automate the entire process? As there is no standard rule book for serialisation in pharma industries, it can get a little tricky when it comes to understanding the whole concept and implementing it successfully. Companies will need resources to plan the implementation part. Also, staff training might become a necessity to ensure you are optimizing the newly introduced process to its fullest.


Not all pharmaceutical companies will be interested in setting up an in-house serialisation department. This is where a vendor comes into the picture. Finding a vendor who brings with them extensive experience in Serialisation integration in the pharmaceutical industry is not an easy task.


Initially, serialisation is going to impact production speed, especially in the packaging phase, the reason being the addition of serial numbers on every product, package, case package, and pallet package.

The manufacturing and packaging facility will need systems to store data generated from serialisation to give users easy and live access. 


The whole concept of serialisation could fail if you do not provide the data for external sharing. There must be systems in place to ensure the secure sharing of data with supply chain handlers and your direct customers.


Product serialisation and managing it is becoming the lifeline of pharma companies and supply and distribution networks. Despite the challenges it entails, serialisation is the way of streamlining the process and taking the security and reliability of pharma’s global supply chain to the next level.

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