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Ask the expert, Pharmaceuticals
Quality assurance (QA) teams working in the pharmaceutical industry have a tremendous and essential job. Their skills are needed to ensure patient and product safety. When a product, pallet, or entire shipment has a temperature excursion, quality teams must review pages and pages of data to determine if the product can be released or must be destroyed. This process can be lengthy, and when you factor in the time of the quality team, as well as product losses, it also has a substantial financial impact. Transforming your operation to a zero-touch release format can help alleviate the strain on your team’s time and improve your bottom line.
The pharmaceutical and life sciences supply chains are complex with multiple distribution centers, shipping modalities, and hand-off points. All these elements pose some level of risk for your products to have some type of excursion.
Real-time supply chain monitoring solutions offer complete visibility into your shipping, distribution, and warehousing operations. Beyond having supply chain visibility, consider how much of the product release process can be automated through pre-set business rules within the technology you’re using. These business rules help your quality teams manage product releases by exception. This means that quality assurance professionals no longer must dig through reams of siloed or incomplete data, often, months after a shipment has already been delivered. The real-time visibility solution from Controlant allows customers to clearly define which conditions result in a product being rejected or released without anyone having to log in and manually update the status.
You and your team know your products best. That’s why at Controlant, we work with our customers to draft business rules that are specific to a product, pallet, or lane. Business rules are typically based on temperature escalations that reflect product quality. They can also relate to logistics, which might include products or pallets not being separated during transit, products not remaining at cross-docks for over a certain number of hours, and so on. These logistics escalations and alerts are likely to affect the product quality as well.
With these business rules set in the background of our wirelessly connected data loggers and proprietary data analytics platform, your pharmaceuticals are monitored 24/7 in real-time. The system and our Monitor and Response Services team catches any escalations or excursions and alerts the appropriate stakeholders. If a pre-defined business rule is broken, the batch is automatically scheduled to be reviewed by the QA team once it arrives at the destination. Our escalations process can also involve freight forwarders in possession or control of products during specific segments of the supply chain. Outreach to them during shipment can prevent quality deviations that would require additional QA review. Customers’ clear set of rules and criteria can be set to that more and more cases fall under the scope of their zero-touch release process.
Our data have shown that temperature is most likely why products cannot be released—it’s approximately 80-90% of the cases. However, there are other justifications for products being rejected, including impurities in active ingredients, damaged products, etc. Our system can receive status updates beyond temperature excursions to facilitate a faster quality assurance process. For one client, in particular, our system monitored the freeze-thaw cycles of its pharmaceutical products. By applying pre-defined business rules to the shipment, Controlant’s data loggers detected the number of freeze-thaw cycles and alerted quality teams of the excursions. The business rules set the severity parameters of the shipment, and certain products were able to be released without further review.
The Controlant system automatically updates the status based on pre-defined criteria resulting in a “zero-touch release” on most products. This automated process shortens the time it takes to get pharmaceuticals to market because you no longer must wait for someone to investigate and then release the batch. The system has been monitoring products along the way, and necessary stakeholders have been alerted if a severe excursion occurred.
We realize that there will always be some cases where zero-touch release does not apply, and your quality review team must manually review the product. We have found that with most clients, the need for a manual product release is under 5%. By managing through exceptions of pre-defined business rules, most products will be released automatically, leaving QA free to investigate truly problematic cases. Having an automatic release and expedited quality review process in the event of escalations or excursions can also assist with root cause analysis and Corrective and Preventive Action (CAPA) preparation.
Quality assurance teams are typically in reaction mode when reviewing batches to release. They are seeing the information for the first time after the escalations or excursions have already occurred. Implementing and using a real-time monitoring solution allows your QA department to operate from a proactive stance. Shipments can be viewed in real-time making it possible to correct an excursion as it is happening.
When products are truly in jeopardy due to a temperature excursion, real-time data allows you to immediately pinpoint the issues. Industry data suggests the average per-shipment quality review time is 24 business hours, and each review costs between $3,000 and $10,000, averaging around $7,500. Switching to a real-time visibility solution can save pharmaceutical manufacturers thousands of hours every year, not to mention millions of dollars. The estimated quality review hours would go from 54,000 hours (or 35 employees) to 2,250 hours (or 2 employees) from industry sources and our internal data.
For example, one pharmaceutical company—after switching to a real-time monitoring solution with Controlant—was able to reduce its overall excursion rate from 6 percent to 3 percent in one year, saving $7M in that first year alone. Additionally, there were no rejections that year for our client. Not only are clients able to reduce hours spent on batch releases, but they can also use the information from any excursions or escalations to have supporting documentation for CAPA plans. This, again, accelerates the process and frees up quality teams on other projects.
Ada Palmadottir is Business Development Director at Controlant. With more than 20 years of experience in pharmacy, management, and technology, Ada has extensive international experience in sales, operations, and marketing, specifically in the areas of product, vertical alliance sales, and partnerships related to pharmaceutical products. She is a licensed and experienced pharmacist and earned a Master of Pharmacy from the University of Iceland and a Master of Business Administration from the Norwegian School of Management in Oslo. Ada has been working with Controlant for the last eight years.