How to identify challenges in serialization implementation and successfully handle them.

Falsified medicines have been a problem across the world for decades. The challenges increased exponentially ever since online purchasing options became available, thereby making global supply chains unsecured. Governments worldwide and Pharmaceutical companies believe that the risks and challenges that come with counterfeiting can be decreased considerably by implementing and enforcing product serialization. With serialization measures in place, it’s possible to reduce the counterfeit drugs from entering the market and prevent tampering and unadulterated medicines.

To successfully implement product serialization, there needs to be a few key factors that must be kept in mind. Some challenges are item-specific, and then there are general product tracking and traceability issues that affect the entire supply chain.

Two significant item-specific challenges can be narrowed down to being packaging related or investment-related. For product track and trace issues that affect the supply chain, the biggest challenges lie with data management and upkeep.

Packaging of products in serialization includes a specific serial number that can link the history and details of a prescription product such as it’s origins, expiration date, the batch number, and the journey information. 2D Barcodes on packaging present challenges of space, readability, and adjusting overprints. The changes made on any barcodes or products must first be met with regulatory approval from the concerned officials, which may affect the entire adaption process.

When companies look at implementing serialization (especially for initial ‘adopters’), there is plenty of initial investment they must factor in, which affects many aspects of the organization such as the manufacturing, packaging, logistics, and validation. The serialization process requires time to set up the necessary software, plan the serialization strategy, and then train employees. It also requires patience and, of course, high costs. The requirements of which may differ based on the needs and size of the organization. Companies must consider initial costs, product-specific solutions, upgrading to new technologies, factoring in country-specific regulations, and all the packaging batches from different facilities.

When organizations implement their serialization strategy, there can be an overwhelming data set volume. A crucial element in managing colossal data is having a reliable software solution containing and effectively sharing vast amounts of data. The supply chain has to host information from across the globe, so it’s crucial to have a system that can develop, maintain, and implement it. Companies must have an efficient data management system in place for their pharmaceutical products to avoid product recalls caused by misprints, packaging related inaccuracies, and poor data processing.