Investment in Supply Chain Visibility Saves Costs
What does GSK´s risk-based approach to monotoring investigational medicinal products (IMP) entail, and why did you adopt it?
A risk-based approach to monitoring investigational medicinal products can help pharmaceutical companies improve supply chain efficiency, but to do this without compromising quality relies on fast access to comprehensive shipment data. Using the TSS cloud temperature monitoring solution and TSS data loggers, GlaxoSmithKline has saved £4 million annually. Rob Montague, Director of supply chain logistics – IMP at GSK; and Niclas Ohlsson, CEO of TSS tell us more.
Rob Montague: The regulators involved in EU GDP, like many regulatory bodies, continue to evolve their thinking in the temperature monitoring and product exposure space. GSK has chosen to focus on quality for the patient as a key driver. Many companies apply the term ‘risk-based approach’ to their decision not to monitor products in transit in certain lanes or at certain times of the year. At GSK, we’ve demonstrated that the vagaries of transportation can cause amazing excursions when logic dictates the shipment should be at low risk. Our definition of risk-based, therefore, revolves around monitoring 100% of our non-cold chain shipments, but varying the amount of packaging based on the actual weather and having the dispatch team understand the robustness of the stability information around the products.
How do you apply the TSS Cloud Temperature Management Solution as part of this process?
RM: Our risk-based approach incorporates information from the stability testing to indicate an alarm on a product. In most companies, once an alarm is received, the first action is to assemble the data from the shipment and then compare it with the stability information to assess the viability of the product. We have switched the order around, so we actually look at the stability information before an alarm is received. When there is an alarm, we know within seconds of the consignee knowing.
Why is capturing all the data so important, and how is this achieved using TSS Data Loggers?
RM: Historically, temperature monitoring models only fed back when there was an issue. To draw an analogy to the safety world, it’s the equivalent of only reporting accidents rather than watching near misses to develop an understanding how something more serious could happen. Having the data available at the destination and origin allows instant access to regulators.
Niclas Ohlsson: From our perspective, having the data from all shipments means we can analyze how well the organization adheres to the corporate SOP.