A global approach to reducing medicine temperature excursions
At the 2018 Temperature Controlled Logistics event, the Senior Director of Global Supply Chain Quality at Genzyme Europe shared insight on reducing temperature excursions and the main challenges complicating these investigations.
The integrity of the cold chain is threatened during transportation by many risks, not limited to natural disasters, handovers and unforeseen delays.
If a medicine’s temperature breaches its label claim this can greatly compromise its integrity, rendering it ineffective or worse – unsafe for consumption.
Facing a potential excursion, manufacturers must be able to verify its status to prevent risking patient safety, but also avoid incurring any unnecessary wastage.
Roman Mijnhart, Senior Director Global Supply Chain Quality at Genzyme Europe presented his temperature control learnings at the industry conference earlier this quarter.
According to Roman, excursion investigations could take anywhere between two – 25 hours from initiation to closure.
He found that 75% of temperature excursions are cold chain related as opposed to Controlled Room Temperature (CRT) products. Excursions are most likely to be seen during transit, with cold chain seeing most excursions occur at the start of the journey and CRT pharmaceuticals being at higher risk of excursions in the last mile.
After examining the transit of three shipper boxes from UK to Canada, Time Out of Refrigeration (TOR) during pack out was deemed influential.
He noted that TOR should be less than three minutes to avoid overshoot and shippers should avoid simultaneous pack outs. Pack outs should also be conducted in a cold room to avoid excursions. Shippers should remember that direct sunlight in a cold room can cause heat excursions.
Benefits can be gained from instilling more operational alignment on a global level with dedicated project logstics teams for excursions. More industry alignment on temperature cycle profiles for vendor chamber studies would contribute significantly to mitigating temperature lapses.
Thermal blankets are sturdy affordable options to limit excursions for ambient pharmaceuticals, especially to protect against any time on the tarmac.
Roman noted one interesting change made with an ambient temperature shipment that managed to eliminate the existence of excursions. This was the use of one pallet containing 30 - 40 shipper boxes to transport the cargo. This positive result did incur a significant cost increase.
Stability budgets calculated correctly prevent shippers from wrongfully discarding drugs in the case of a temperature deviation in transit.
A medicine’s actual Time spent Out of Storage (TOS) is compared to the allowable excursion time depicted in its stability budget. With this stakeholders can make quality-based data driven decisions on what to do with a pharmaceutical and whether it is safe for consumption. More support is needed from providers for recording TOS, perhaps via cloud systems.
Senstitech notes that the stability budget should ideally be distributed through the entire lifecycle, with fixed periods dedicated to manufacturing and storage. Excess time should be utilized upon distribution.
ELPRO explained: “By proactively setting up and managing a stability budget, you solve the issue of QA running around doing manual investigations with CROs and LSPs for multiple legs of a shipment taking days, sometimes weeks.
“Quicker decisions at the end of shipment avoids delays to patient administration, and keeps the supply chain in control.”
In our recent research, over 75% of the temperature controlled logistics practitioners surveyed voted in favor of increasing the use of product stability budgets for decision making in the supply chain.
This overwhelming consensus was noted in Pharma Logistics IQs 2017 report Optimizing The Path From Lab To Patient over 140 industry professionals.
Even though stability data is a great tool for combatting excursions, Roman highlighted the practical challenges that still exist with stability budgets. For example, the question of whether a shipper has full term stability data after an excursion.
Regulatory requirements regarding stability budgets vary according to region. When it comes to parallel distribution this conflict in requirements can result in what some call ‘stability label claim soup’.
Regulators are likely to enquire about the protocol deployed to generate the stability data and the implementation of a stability budget.
Acceptable ranges for TOR require a risk based approach, increasingly inspectors are now asking for this to be in place and backed up with documentation.
In a previous whitepaper, Dr. Rafik Bishara Ph.D, Technical Advisor, Retired Director, Quality Knowledge Management and Technical Support, Eli Lilly and Company stressed that to avoid implementing a stability budget is in fact taking on a risk – dependent on the inspector they are allocated and whether that inspector decides to focus on the stability budget.