The Hottest summer on record occurred this year with temperatures soaring to 40oC in July 2022. As a medicinal product wholesaler what key learnings with regards to your transport have you taken away? What are you going to implement to prevent excursions next year? With climate change encouraging the more extreme temperatures act now to protect your products from the ever-changing climate.
Questions you should be asking:
Temperature controlled solution
Combined with the new green guide issued by the MHRA the time for temperature-controlled solutions have finally arrived. Whether that is using a passive shipper or temperature-controlled vehicles all wholesalers who utilise an uncontrolled solution should be considering a solution who offer stronger protection to maintain the products specification.
Risk assessments
From route to mode of transport, your risk assessments require review, do they still accurately reflect your model including temperature extremes. Does your validation quantify distribution during the heat? If it does where is your limit and what justification do you have for that limit?
Packaging
Does your packaging continue to provide adequate protection against temperature? Do you need to consider additional protection? Is your level of packaging protection quantifiable against the payload?
Suspension of service
This was a very traditional approach to extremes in temperature however, as the heat is lasting for weeks rather than days now, is this still a viable solution? Do you have the capacity to store orders awaiting shipping? What is your limit before suspension? Who makes that decision? How do you justify the limit? Are your customers happy to wait?
Think about the bigger picture what do you need to implement now to prevent further excursions later? Do you have a change control in place? Do you have a CAPA?
PLC can help, contact us for more information or to speak to one of our RPs.
