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Organizations operating in today’s pharmaceutical industry must bear a far greater responsibility than they did in the past. For as long as there has been a pharma industry, there have been rules and regulations that govern quality and effectiveness. However, since 2013, pharma manufacturers now have to use an electronic system to identify and trace prescription drugs throughout the entire manufacturing and distribution cycle.
This idea is known as pharmaceutical serialization, and it is designed to counteract fraud to keep the public safe from counterfeit drugs. In the United States, the moves were enshrined into law by the Drug Quality and Security Act of 2013, but similar regulations have been rolled out all over the world. This means that all manufacturers and distributors — across all domestic, and most international, markets — need to be on top of serialization of pharma products.
But how do we make sure that this serialization is handled in the proper manner? How do manufacturers and distributors future-proof pharmaceutical serialization so that it stays fit for purpose in the long term?
Achieving a Fully Future-Proofed Serialization Solution
There are a number of actions we can take to make sure serialization in pharma is achieved in the right way.
Define Your Technology Levels
Serialization solutions are deployed across four key levels of technology, and each of these levels can be future-proofed to ensure ongoing compliance and effectiveness. These are;:
- At the device level
Code readers that process serial numbers, printers and scanners that are used for developing labels — these are all found at the device level.
How to future-proof?
Implement regular assessment and testing for all devices. Understand that devices will need to be updated and upgraded on a rolling basis, so define a schedule for deploying new hardware before the existing hardware ceases to be effective.
- At the line level
Immediately above the device level is the line level. This is where software is deployed that collects and manages the data from the hardware at the device level. Here, software supervises and monitors this data in real – time, as well as providing provides an interface for human interaction with the data.
How to future-proof?
Much of the functionality at this level can be automated. Deploying automated solutions removes the human element from arduous analytical tasks, while machine learning ensures that the solution stays effective in the long term with little human interaction required.
- At the site level
At the site level, software and hardware is are deployed to manage the data handled at the line level, and also as well as to connect this to business logistics systems that oversee the whole solution. It is this site–level software and hardware that generally oversee operations at each packing facility so that organizations can stay on top of pharma serialization before the products leave the business premises.
How to future-proof?
Software automation and the same process of hardware assessment and monitoring as adopted for the device level can be used to future-proof solutions at the site level. The ISA-95.00.01-2010 international standard governs solutions at this level, and a pro-active proactive approach to updating and upgrading helps to ensure ongoing compliance.
- At the top level
At the top level, Business Logistics Systems oversee serialization on a business-wide level. These systems keep track of data and processes at each level of the solution and offer business owners a clear vantage point from which to assess the effectiveness of the system.
How to future-proof?
Business logistics systems can be integrated with Enterprise Resource Planning (ERP) systems. This means that data can be handled and managed in a more effective manner , and can be used to derive critical insight into the performance of the business. This approach ensures that any inefficiencies in the serialization process are caught ahead of time , and ironed out on an ongoing basis to ensure the continual development of serialization within the organization. As with other levels, a proactive process of updating and upgrading business logistics systems also keeps the solution effective in the long term.
Consider Working with a Third–Party MSP
It is not always easy for businesses to stay on top of their responsibilities under pharma serialization regulations. As errors in this field can be costly, it may be a good idea to seek the assistance of a third–party MSP, or Managed Services Provider.
This provider will oversee the deployment and management of the serialization solution, ensuring full compliance both in the short and long term. While there will be an ongoing fee for this service, the peace of mind an MSP can provide is likely to make this worthwhile.
Only work with MSPs with a solid track record of providing this kind of pharma serialization service. Serialization is a highly specialized field. And, and elements such as tamper prevention, 2D data matrices and product returns and recalls add even more complexity. Seek out industry reviews and testimonies from former and existing clients before making your choice.
Think About Potential Changes to Legislation
Any changes that are made to pharma serialization regulations will be announced ahead of time, giving . This gives you and your business plenty of notice as you make changes to your policies. One example of this is the aggregation of data, which will see the linking of pharma product data and case data.
Currently, this will not be mandatory in the United States until 2023. However, to avoid being caught short, pharma manufacturers will still need to be proactive and to begin the transition towards this new requirement early. Make sure that your team, or that of your MSP, are is actively engaged in news and updates regarding serialization so that you have enough time to make any changes that are required.
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Product serialization is undoubtedly a good thing for the pharma industry and for consumers. However, it does make life a little bit more complicated for manufacturers and distributors. Working to future-proof your solution will certainly pay dividends , as you will be prepared for any changes made to regulations, and will. You will also be able to complete these changes ahead of time with little to no disruption to your business.