By Kevin Stolarski
October 16, 2020
While Pharmaceutical product serialization is being introduced throughout the world, it is certainly not something new to drug manufacturers in the U.S. In November 27, 2018, the U.S. Food and Drug Administration (FDA) put into place the Drug Supply Chain Security Act (DSCSA) that requires product tracing schemes for drug manufacturers and re-packagers and requires them to place a unique product identifier, which is also known as serialization, on each package of human prescription drug product introduced to the market. Since then, regulations have only grown stricter. Since November 27, 2019 pharmaceutical wholesalers have been required to buy and sell only serialized drugs. In addition, re-packagers were also required to buy serialized drugs. By November 27, 2020 all dispensers of medicines must buy and sell only serialized drugs and finally, by November 27, 2023 a full enhanced drug distribution security comes into effect, meaning every individual container of a pharmaceutical or healthcare product must be serialized.
The core purpose of serialization is to reduce the ability of counterfeit medicine to enter the supply chain, while at the same time enhancing patient safety. But for pharmaceutical manufacturers to meet the requirements of serialization, this involves careful planning and considerable cost. Large pharmaceutical companies can easily afford to upgrade their production and supply chains with the latest serialized packaging equipment, and also establish central track and trace systems to handle the extra complexity that may get introduced by the FDA. However, that is typically not the case with small and midsized pharmaceutical organizations who are often not even fully aware of all the regulations. Their operational systems may be generic and not fully integrated with their production and supply chain. This forces them to work around these requirements with manual processes that results in loss of flexibility, speed and revenue.
Temporary operational solutions for small pharmaceutical companies need to be replaced by strategic approaches that address the topic of serialization before they are a burden for the whole business, and before the FDA imposes fines for not meeting their guidelines. Serialization is indeed a complex process that affects your entire organization far beyond the packaging line that requires careful planning and strategy. Here are just a few things your small pharmaceutical company will want to consider.
Product Volume and Storage
Serialization will introduce a massive volume of data and with that comes storage requirements. Calculating the amount of information you’ll need to manage is an essential part of your planning. This may depend on the amount products or drugs you plan on manufacturing. This will give you a better understanding of the total serial numbers you’ll need to create on a regular basis. For many companies, this may mean billions of records of data. You’ll also need to be able to retain and access this data easily for years to come.
No one department of individual will be able to singlehandedly address your serialization process. Representatives from across operations should be involved. Consider pulling in resources from, Compliance, IT, Supply Chain, Quality, Validation, Packaging, and Training, and any third-party vendors such as CMO that maybe helping you manufacture and distribute your solutions.
Do you have an idea of how you will package the product and where your serialization code will be placed? How much downtime will line upgrades require? Do you have enough stock to meet the demand of your drug or product? And again, how are you managing all this data?
Third Party Logistics and Contractors
Do your third-party contractors have plans and timelines to upgrade their dedicated lines of your product? Will they be ready to provide verification information to wholesale distributor? Are there any increased fees for their services? Make sure these conversations occur early with your pharmaceutical partners.
If you use an enterprise resource planning (ERP) system you’ll likely want to integrate it with the serialization solution you choose. Pharma companies who use SAP as their ERP system (ECC or S/4 HANA) can seamlessly extend their solution with SAPs Advanced Track & Trace for Pharmaceutical (ATTP). Smaller companies that have not implemented an ERP solution can also use this solution as a stand-alone service. As you evaluate serialization solutions, consider which ones have pre-built integrations with your core business processes.
Who can help put together a serialization plan with a solution that meets all the requirements for serialization? As you begin strategizing for your sterilization project consider finding a solution provider that specialize in small and midsized life science companies that often deal with compliance and regulatory demands. Outside of their expertise, make sure you have a partner that meets all your requirements, such as global demands, to help support you through ongoing regulatory changes.
Map out when you will need to deliver a serialized product to market. Then work backwards, taking into consideration your manufacturing lead time, how long line upgrades will take, and/ or when you may get FDA approval on your drug. These often need to happen in a very short period.
Serialization knowledge and track and trace technology is becoming wider spread and more accessible, but it’s still far from being a commodity within small pharmaceutical companies. The path to full serialization is different for every company. Some choose to serialize in phases, others tackle the entire challenge in one fell swoop. The choice really depends on your specific objectives and available resources. However, organizations that can’t remain agile and flexible and comply with regulations will continue to lose market share to the companies that are able to focus on their business processes.