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 that quality and supply chain professionals working within the pharmaceutical industry not only comply with regulations and processes within their own organization, but ensure that they are working closely with all of their partners to collectively comply with the relevant 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 various stakeholders involved, but there may be a variety of entities involved at each step. As a pharmaceutical enterprise, patient safety and your brand are at risk if something in your supply chain goes awry. Gaining peace of mind that medicines, vaccines, and medical devices are securely maintained at safe temperatures throughout the entire journey, from API manufacture to the last mile distribution, remains a challenge as global supply chain complexity increases. 

Adopt a fully-validated solution for compliance

To comply with GDM and GMP, as well as track and traceability regulations such as the US Drug Supply Chain Security Act (DSCSA) and the European Union (EU) Falsified Medicines Directive (FMD), it is vital that all of the people and organizations along the supply 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 temperature-controlled supply chain—or 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 to ensure patient safety, reduce waste, and ensure compliance.

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, manual 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 supply chain data and share it with stakeholders.  

Expedite shipment release time and manage by exception 

Choosing a solution that is not only fully validated, but that also offers real-time monitoring adds an extra layer of value to your supply chain. 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 that a shipment requires further investigation. This enables stakeholders to manage by exception and only look into those shipments where excursions occur. In addition, receiving shipment data in the moment increases the likelihood that corrective action can be facilitated before pharmaceutical products are wasted.

Having the historical excursion data at your fingertips adds even more transparency as that data can also be shared with logistics partners and freight forwarders. Providing these stakeholders 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. Maintaining this data in-house also alleviates reliance on third party stakeholders for accurate supply chain data; the data is simply yours.

Over time real-time data can be used to better predict when, where, and how temperature excursions occur. This enables pharmaceutical manufacturers to manage supply chain risk and drive continuous improvement. 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 a pharmacy chain, you are expected to know whether the products leaving your part of the supply chain have been kept safe and secure. Being able to quickly and easily generate custom reports on your cold chain data and share it with the relevant stakeholders 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 a deviation occurs. This allows you to more quickly react to prevent excursions as well as to quickly identify the root cause of an event, enabling you to prevent similar incidents in the future.  

Controlant’s cold chain monitoring solutions are 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 professional add-on services, including 24/7 monitoring and response, integration support, and IoT asset management. The trifecta of Controlant hardware, software, and services are sold as a packaged subscription service. This means you always have calibrated loggers on hand, access to the Controlant user interface, and we can monitor your supply chain 24/7, 365 days per year.  

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