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Temperature-Controlled Logistics Trends to Watch

The ISTA Pharma Committee's annual Technical Exchange highlighted a shift: regulators placing focus on performance qualification data. Also discussed were industry thoughts on climate change, ambient profile development, and more.

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In a banner year for cold chain products thanks in part to COVID-19, experts remain hard at work furthering industry standards and best practices, promoting collaboration among pharmaceutical end users, suppliers, distributors, and service providers.

At the ISTA Pharma Committee's annual Technical Exchange, stakeholders gathered for an open discussion about trends in temperature-controlled logistics. (Here are links to recordings of Session 1 and Session 2.)

Regulators seeking PQ data

One attendee noted that they’re now being asked to provide more actual shipping data vs. lab testing or operational qualification (OQ) data as representative.

Arminda Montero, associate director, global supply chain quality at AbbVie Inc., confirmed, “Yes, we’re seeing an increasing trend by regulators wanting to have PQ [performance qualification] data in submissions, not for CRT [controlled room temperature], but for frozen and cold chain products. We've seen more and more countries asking for that beyond Brazil, the U.S., Canada, and Australia.”

Regulators want to see that the design or the chamber testing is actually representative of the shipping conditions. As Montero noted, there’s an ongoing discussion about whether that data needs to be from a PQ or from a performance verification process. The key takeaway: regulators are seeking actual shipping data.

Climate change and temperature profiles

Climate change impacts the frequency and severity of weather events, and temperature-controlled logistics experts will continue to navigate these changes. Is the profile data collected in the past keeping pace with current events?

Bill Mayer, director of research and development at Pelican Biothermal, said that this is a relevant topic they’ve discussed in group review sessions regarding gathering lane data for the new Ambient Temperature Profile Best Practice Guidance. The group is still considering what should be gathered over what time period and how often this data should be reviewed.

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