Questions to ask when Outsourcing your Cold Chain Logistics

When outsourcing services in the life science industry, it is crucial to know what requirements to impose on a carrier; both to uphold control as well as to please regulatory agencies when they come to visit. Geoff Stairmand, former supply chain project manager at AstraZeneca, guides you in what questions you can ask to ensure you and your carrier will stand up to regulatory scrutiny.

In the heavily regulated pharmaceutical landscape, the demand for compliance and visibility is persistently increasing. Although the services as such can be outsourced, the responsibility for assuring compliance will still lie with you as the outsourcing company. During a recent audit at a global pharma company, the MHRA even requested access to the company’s web system in order to obtain complete product temperature and shipment data, and thereby full visibility. The company could present a lean and secure cloud solution for securing and accessing the complete set of data records, which appeared to meet and exceed the MHRA’s expectations. In other words, locally saved pdf files with temperature data will most likely no longer go down well with auditors; they call for increased visibility

Raising the bar

Stairmand explains that neither is it sufficient to prove that pharma products – CRT and cold chain – have been in the right condition through a local accessible document with an employee’s signature. Instead, regulators ask for access to the system containing all auto-stored data records, in addition to seeing the full chain of custody. Preferably, this system should be a cloud solution that allows you as pharmaceutical company to gain visibility, in order to subsequently maintain quality and a state of control.

The demand for more visibility is further enforced by regulatory bodies taking a critical view on the processes in which temperature data records are saved only when a temperature deviation occurs; what about the shipments presumably without deviations? Providing instant access to all temperature data records when an inspection is due can save you and your company from serious findings. Even more important, by having access to all records, you know the facts for all shipments – not just those stated to be out of range

Impose the right expectations on your carrier

The decision of companies to outsource extended services, such as letting carriers perform temperature monitoring, can bring a number of advantages such as saved time and money. However, outsourcing also infers risks that could have a fatal impact on patient safety, if the carrier is not carefully evaluated. Remember, accountability and responsibility for compliance with regulatory requirements, as well as ensuring patient safety, can never be outsourced.

Even though carriers share the fact that they take products from point A to point B, they will use different solutions for transporting and monitoring shipments. Also, an increased number of carriers used implies a risk for decreased visibility, whereupon life science companies face a huge challenge in obtaining a holistic distribution perspective. To tackle this, you as the outsourcing company should be the owner of the temperature monitoring solution and in control of the cloud in which all temperature data will be stored and accessed; also in hindsight. From a business continuity perspective, historical data is just as important as that of today.

Visibility is key

Although certain services can be easily outsourced, this does not hold true for the responsibility for visibility and subsequently compliance; these important aspects cannot, and should not, be put on someone else. When it comes to monitoring life-saving drugs, compliance to quality standards is a prerequisite. Complete visibility is therefore key when it comes to being compliant with the current GDP guidelines enforced by the regulatory agencies.

Do not worry, time and cost savings can still be gained by outsourcing the handling of temperature monitoring devices throughout the supply chain. As long as visibility and control is maintained by the company, operations on device level may be outsourced to any number of carriers. At the same time, you can benefit from the savings of outsourcing as well as be prepared for future audits.