Working with your suppliers and partners to achieve pharmaceutical cold chain compliance with real-time monitoring

Pharmaceuticals, Cold chain management   29 Nov 2018

Whether a CMO, supplier, wholesaler, distribution or logistics partner, it’s imperative for quality and supply chain professionals working in the pharmaceutical industry not only to comply with regulations in their own organization, but ensure they’re working closely with all of their partners to collectively comply with those regulations. 

Organizations all have their own internal processes, resources, and tools to ensure quality and compliance. At each stage of the supply chain there are not only different people involved, but it’s often a completely different organization handling each step. As a pharmaceutical enterprise, however, it’s your brand and your patients that are effected if something goes awry. Getting peace of mind that medicines, vaccines, and medical devices are safe throughout the entire journey from API manufacture to last mile distribution can be challenging to say the least. 

Adopting a fully-validated solution for compliance

In order to comply with GDM and GMP and track and traceability regulations such as the US Drug Supply Chain Security Act (DSCSA) and the European Union (EU) Falsified Medicines Directive (FMD), it’s important that all of the people and organizations along the chain are also complying. Strict record keeping, access to critical data, thorough review, and a close working relationship with partners are all integral parts of ensuring compliance. When it comes to the cold chain, pharmaceutical products must be manufactured, distributed, and stored under strict temperature and sometimes humidity conditions. The audit trail for this data is extremely important in order to ensure patient safety, reduce waste, and get peace of mind you are working within strict regulations.

Having a tool fully validated tool to monitor these environmental conditions is critical. As the pharmaceutical supply chain moves from a cost center to a competitive differentiator, it is also becoming more digital. The days of cumbersome pdf reports and paper trails are numbered as technology evolves. It is now easier than ever to implement IoT (Internet of Things) technology combined with on-demand, cloud-based solutions to aggregate your cold chain data to share with stakeholders and ensure manufacturing and distribution partners throughout the entire chain. 

Quicken the release time and manage by exception with real-time monitoring

Choosing a solution that is not only fully validated, but also offers real-time monitoring adds an extra layer of benefits. Monitoring temperature-controlled products in real-time means that not every single shipment needs to be investigated before release. If alerts and notifications are sent at the moment temperature starts to go out of bounds, supply chain and quality professionals will know whether or not there was an excursion during a shipment even before investigating for the root cause. This allows them to manage by exception and only look into those shipments where excursions occur. Not only that, but receiving the data in the moment, means the likelihood of proactively saving high-value products before they’ve been ruined increases. 

Having the historical excursion data at your fingertips adds even more transparency as that data can also be shared with partners. Providing them with reliable data to back up your efficiency builds trust with your partners as well as your patients, effecting both your brand image and your business relationships. This can even be taken a step further. If you can leverage the real-time data to better predict when, where, and how excursions occur, you’ll be able to reduce the likelihood of them happening in the future. This not only increases ROI, but it can help lower insurance costs, save time, and make your organization one that others trust and want to work with. 

Share cold chain data with stakeholders 

Whether you’re a CMO, a distributor, wholesaler, warehouse, or pharmacy, you’re expected not only to know if the products leaving your part of the chain are safe, but also those entering your domain. Being able to quickly and easily generate custom reports on your cold chain data and share it with the relevant people is imperative to promoting transparency and achieving end-to-end visibility. 

Adding location data to the mix further increases this visibility and provides insights into who is responsible for the products at the time and place an excursion occurs. This allows you to more quickly react to excursions as well as more quickly identify the root cause of the event, enabling you to prevent similar incidents in the future.  

Controlant’s cold chain monitoring solution is fully validated for CFR Part 11 / Annex 11. It combines re-useable, IoT data loggers with an intuitive cloud platform and a suite of managed and add on services. The Controlant hardware, software, and services are sold as a packaged subscription service. This means you always have calibrated loggers on hand, access to the user interface, and we manage your reverse logistics and can monitor your supply chain 24/7, 365 days a year with our monitoring and response team.  

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