Stability Data Sharing in Canada’s Cold Chains
Lately, the need for heightened awareness and use of stability budgets within cold chain has been an industry focus. In a recent article Dr. Bishara and Dr. Erik J. van Asselt explained that a stability budget: “Refers to the quality of a product to resist, under specified conditions, irreversible change in its identity, strength, quality, and purity at various temperatures above and below the labelled claim storage temperature.
“.... The drug degradation] rate depends on several factors including but not limited to the physical and chemical properties of the active pharmaceutical ingredient, formulation, pH, temperature, water and oxygen sensitivity, light sensitivity and primary packaging. “ (6)
In explaining the importance of deploying a stability budget, Dr. Bishara noted that “the effect of not knowing your stability budget, calculating it correctly, and most importantly, implementing it on a quality-based standard, is that you may discard medicines and vaccines that are good – or approve the utilization of pharmaceuticals and vaccines that have been exposed to excursion that has resulted in the degradation, lack [of ] efficacy and potency. So by knowing your budget, calculating it correctly, and implementing it during the supply chain in case there is a deviation or an excursion heat or freezing you will be able to make quality-based data decision on what to do with this material.”
The time out of storage (TOS) can then be calculated and compared to allowable excursion time. By using the allocated TOS, packaging and manufacturing stages can be conducted in ambient temperatures for cold chain products. Manufacturers can then benefit from improvements in machinery and employee performance. However, this could impact the product’s shelf life, so this time needs to be measured and balanced. TOS can be useful in managing temperature excursions. Hazards within transportation represent larger threats to the cold chain with the prospects of physical contact, handovers and unforeseen delays.
When considering Canada’s extreme temperature ranges and vast territories, it is clear that the region’s cold chain stakeholders would benefit from the flexibility provided by stability data. In reality, however, there is a lack of end-to-end transparency along the supply chain with stability data. Reasons for this are driven by the legal responsibilities attached to decisions made with excursions.
Louise Labelle, Affiliate Quality Leader, Zoetis explains that manufacturer importers are reluctant toshare this information because there is more than one factor to take into consideration with excursion decisions. Depending on the nature of the product and the temperature excursion, an assessment needs to be made. For example, there may be several excursions for a specific lot during manufacturing, packaging, inbound transportation, storage or outbound transportation. For some products the duration of the excursion is additive and wholesalers don’t have a comprehensive history of the product to make an evidenced decision. “Despite this, manufacturers and importers are the ones who are responsible for any adverse events of a product.”
Ahead of the 15th Annual Cold Chain GDP & Temperature Management Logistics Summit we explore the state of affairs in the general industry as well as specifically to Canada in regards to stability data use in the cold chain