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Is Stability Data really a Superhero? Using a Budget In Practice

At the 2017 Leading Minds Seminar in Princeton, New Jersey, Emanuel Schäpper, Team Leader Key Account Management at ELPRO presented an overview of why companies are increasingly using stability budgets to manage their temperature controlled supply chains. Saving cost and resources in processing temperature excursions are key benefits of using stability budgets. What seems to excite pharma companies the most however is being able to save stability for the last miles by having control and visibility of Time out of Refrigeration throughout the supply chain.

Mr Schaepper discussed how every product has stability limits, if you have the data – why not use it? In every supply chain there going to be uncontrollable circumstances and temperature deviations will occur. But how much effort is invested in handling excursions? The audience discussed time as a major factor in handling excursions, but also using resources of people, limiting stock and availability of products, costs of reproducing and repacking and ultimately cost of product loss. Download the presentation here.

The presentations included two case studies of pharmaceutical companies who use stability budgets, and how the number of excursions reduced by implementing alarm criteria based on stability data. 

For companies who haven’t used a stability budget yet, there are several ways to set one up:

    • Logger Configured

    • Post Shipment Assessments with analysis software of cloud database

    • Stability Budget Management System

    • Long -Term Continuous Monitoring

One such device for long-term continuous monitoring is the Libero ITS, a long term indicator that gives one source of data along entire supply chain, including ‘one touch’ stability budget read out. Read more about it here.

Haven’t used a stability budget yet?

    • Start out by analyzing your data.

    • Calculate deviations that could have been avoided.

    • Create a business case.

    • Find an easy way to implement that makes sense for your current processes and multi-step supply chain.

To discuss in detail how to get started, please feel free to contact ELPRO here.

To read the highlights and practitioners best practices in the post event report of the Leading Minds Seminar 2017, please visit here.

To join us at a future Leading Minds Seminar.

Stability discussion topics will include understanding how to comply with some international regulators who only accept label claim; types of stability studies earlier on that can smooth the distribution environment, and comparing company approaching to building stability budgets. All pharmaceutical manufacturers are invited on a complimentary basis.

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