Sometimes, businesses invest in technology and infrastructure to meet government regulations. Other times, they do it to improve processes, decrease risk, and maximize revenue. And occasionally, both drivers come into play at the same time. Serialization in pharmaceuticals and biotech is a perfect example of this.
The Drug Quality and Security Act of 2013
The global market for counterfeit drugs is expected to reach $200 billion by the end of 2015. In response to this issue and to control and mitigate the risks posed by counterfeited, adulterated, and diverted pharmaceuticals, the Drug Quality and Security Act of 2013 was developed. The primary purpose of the law is to prevent dangerous drugs from entering the pipeline of legitimate drug production and delivery. The Act accomplishes this by requiring drugs and other pharmaceuticals to be traceable at every step of the process, from the manufacturer to the end user. And this isn’t taking place only in the United States – governments across the globe are taking similar action, although the methodologies differ somewhat. But what it all comes down to is that businesses involved in handling pharmaceuticals or other biotech products will soon have to provide step-by-step by traceability, or a chain of possession, in other words. This requires a considerable investment of capital, time, and training.
How traceability works
When you have full traceability in place, you can take any biotech product you’ve handled and tell when it was received (and all the facilities it came through before it got to you), who received and handled it, where they put it, what actions (if any) were taken in preparing the product for proper storage or shipment, and more. In a nutshell, serialization traceability allows you to not only find a particular grain of sand on a beach, but also to have access to its entire history. And when you’re handling products that affect customers’ health, that’s important.
The challenge for businesses, of course, is how to achieve full traceability, and it starts with serialized bar codes. But having the ability to print serialized bar codes doesn’t do you any good if you don’t have the equipment and technology to read those bar codes and store information about them during every step of the process. So, by the time the law goes fully into effect – which will happen at different times for different parts of the supply chain – anyone handling pharmaceuticals or other biotech products will need to have a complete inventory management system in place that includes scanners or RFID readers as well as the computing power to store, analyze, and report the data.
Compliance’s silver lining
While companies that wish to participate in pharmaceutical and biotech markets will have to come into compliance to stay in business, there are significant benefits to this that might not be obvious right away. That is, the systems that make complete traceability possible bring with them numerous other positives, including:
- Better financial controls
- More accurate inventory management
- More precise execution of recalls (which results in savings realized by recalling only the products that are affected)
- Improved employee productivity
- Reduction in mistakes due to human error
- Enhanced ability to plan for and monitor inventory rotations and expiration dates
In other words, this is one instance in which complying with government regulations will give businesses a legitimate, verifiable, bottom-line reason for investing in tools and processes that will help their businesses run more efficiently and at a higher level of profit.
Next steps
Partnering with a vendor that understands both your business and the coming regulatory requirements is a critical first step. QStock Inventory has years of expertise in traceability, and we’re here to help you set your warehouse up the right way – the first time. Our QStock Warehouse Management System integrates seamlessly with both QuickBooks and Intacct, which offers an additional increase in productivity – no data entry required – and a corresponding increase in accuracy. Contact us today to learn more. We’d love to talk to you about the upcoming regulatory requirements and what we can do to help you come into compliance while also increasing productivity and accuracy on an enterprise level.
