What are the challenges of serialization?

Product serialization is extremely important for the pharmaceutical industry. The pharmaceutical sector ships products that are vulnerable and fragile, but indispensable for the well-being of all people. Due to the life-critical nature of commodities along the drug supply chain, pharmaceutical manufacturers must always have product serialization as an operational priority.

 

Why serialization matters

Serialization is crucial to maintain the integrity of the supply chain. By giving businesses and organizations the ability to efficiently keep track of their products, the serialization process guarantees the safe delivery and transportation of merchandise.

Benefits of serialization in pharma

 

8 challenges of serialization

 

1. Technological serialization requirements 

The serialization process requires the use of specialized technology. Proper supply chain management implements serialized data in a digital form, and this digital information must be able to go back and forth between locations and computer screens instantaneously. To achieve this, a business must invest in hardware and software solutions. 

Some methods of serialization for a supply chain track whole batches at once. Others, however, implement special codes unique to every serialized product. Often displayed in the form of a QR code, these serialized codes can be used to track every unit of merchandise from the moment they are packaged until they reach consumers.  

Since drug manufacturers need to have the most accurate data about the location and integrity of their products, the serialization method chosen for a pharmaceutical supply chain should be the most precise. The best methods of drug serialization adapt to the particular needs of a business.

 

2. Regulatory compliance and serialized products

To be able to do business in a country, a pharmaceutical company must adhere to the local rules and regulations. Different countries can have wide variations in the content of their legal codes, leading to many potential risks for pharmaceutical manufacturers who don’t take proper precautions. Improper screening of wholesalers, for instance, can lead to dealing with unauthorized parties, which could result in fines and prison time. 

To create a global standard for good practices in the serialization of pharmaceutical products, an initiative known as the GS1 has been created. The GS1 is a global non-profit organization whose goal is to provide drug supply chain security measures on an international scale.  More than 100 countries have adopted the guidelines of the GS1, so adherence to its guidelines can help companies join the global marketplace.

 

3. Training personnel 

Efficient pharmaceutical supply chain serialization requires adequate knowledge of various processes. All employees in enterprise and production environments who come into contact with the serialization process must be trained. Not only should the personnel responsible for scanning barcodes understand how to carry out their duties, but those handling supervision tasks should be familiar with the data they are monitoring.

The development of internal supply chain experts should be a primary goal. Serialization training must be multidisciplinary to account for the vast range of topics covered by the practice, including IT, engineering, production, automation, and quality testing. Due to the volatility of the markets and periodic changes to software, serialization requirements may differ in time. Therefore, companies should keep in mind that re-training might be a requirement in the future.

 

4. The global scaling of operations

Expanding at an international scale is a great milestone in the development of any company. Business opportunities suddenly grow exponentially, and new markets represent a huge potential for profit. However, growth also comes with its share of risks and liabilities.

The complexity of supply chain processes may vary depending on a company’s business model or the geographical location it is doing business in. A pharmaceutical supply chain serialization solution should therefore adapt to an organization’s specific needs.

With a focus on constant improvement, Nubino provides effective pharmaceutical product serialization regardless of structural and environmental factors. Working alongside supply chain partners on a global scale, Nubinno possesses the technology and know-how to expand pharmaceutical supply chain operations.

Drug serialization services

 

5. Pharmaceutical reconciliation

Pharma reconciliation is a process performed to monitor all the materials used in the development of pharmaceutical products to guarantee that all finished goods are taken into account. This process oversees that all serialization numbers are properly utilized and that no errors have occurred. The purpose of this practice is to ensure customers and regulatory bodies that every product is safe and of good quality.

The pharmaceutical reconciliation process can be separated into three stages: 

  • Pre-lot reconciliation: During this stage, serial numbers are created for all the items on the packaging lines. 
  • In-lot reconciliation: This stage of the process allocates serial numbers to products. In case it is necessary, numbers for aggregation are also included. It is possible for some of the serial numbers to be discarded, as there may be technical, material, or quality problems.
  • Post-lot reconciliation: At this stage, the product is packaged and ready for use, but hasn’t left the custody of the manufacturer. It is possible for stock at this moment to be in staging, transit, or located at a warehouse. 

With the use of modern serialization solutions, a pharmaceutical company can keep track of its stock even after it has left its immediate control. In fact, through smart serialization implementation, pharmaceutical businesses can even have contact with the clients who buy their products.

How does pharmaceutical serialization work?

 

6. Promoting customer loyalty

Not only is pharmaceutical product serialization indispensable for the safe and efficient transport of medicines, but it may also be the future of pharma marketing. Customer trends are shifting, and companies in the pharmaceutical sector need to adapt in order to thrive in a changing global marketplace. 

Pharmaceutical companies face the challenge of turning the tools of serialization into a vehicle for establishing bonds of trust with their customers. Since the printing of unique codes is already part of the serialization process, pharma companies can repurpose these codes to establish a line of communication between the brand and its consumers. 

For instance, customers can be offered access to discounts and information by scanning the serialization code. These actions have the potential of increasing brand recognition and customer engagement. Furthermore, companies applying customer loyalty methods can have access to valuable insights about market performance, as they know exactly who is buying their products.  

 

7. Supply chain data management

Drug supply chain implementation generates vast amounts of data. Every single time a barcode is scanned, data is generated. To be efficient, this data must immediately travel to a database, from where it can be accessed.

However, if there is no specialized software solution to analyze and report on gathered insights, then they pose no benefit for the company running the supply chain. A report by Seagate acknowledges that 68% of data available to businesses goes unleveraged (source), denoting a huge gap between current data usage and its hidden potential. Good use of data is one of the main supply chain challenges for pharma companies. 

If serialized data is used properly, many benefits can be reaped from it. Analysis of functional insights can lead a company to accurately assess the performance of all products on the market, improving the ability to estimate product demand. Moreover, companies can design new strategies using data as hard evidence to support decision-making. 

 

8. Building trust and forming partnerships

Building strong partnerships is one of the greatest challenges faced by upscaling businesses. The integrity of a supply chain at an international level requires that products change hands multiple times, and it is far better for a pharmaceutical company if those are hands it can trust.

If a company does business with the wrong supply chain partners, it increases the risk of unfavorable outcomes happening. For example, ill-natured partners may incur product diversion, where stock is illicitly delivered to unauthorized vendors without the knowledge of the manufacturers. Not only are a company’s profits and reputation at stake, but also its legal standing in the country or region where the malicious practices have been performed. 

For companies experiencing expansion for the first time, it may be daunting to look for partners who share their vision and goals. Luckily, pharmaceutical companies can join Nubinno Connect and use its global business development services to find the right associates. 

Nubinno has partnered with the largest saaS pharma serialization company, giving the partnership the ability to deliver certified implementation and support services to many parts of the world. Furthermore, Nubinno’s project management and hardware installation services are developed in conjunction with a large Cloud Analytics Company, providing all clients with the best supply chain security and efficiency. 

Nubinno connect is a business development network built by experts in the pharmaceutical sector meant to unite companies with similar strategic goals. With over 1000 partner pharma companies in Europe, Asia and America, Nubinno connect is an effective tool to increase global client reach.

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