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Pharmaceutical Manufacturing and Packing Sourcer

Cold Conditions

The global pharmaceutical industry is continually striving to meet and exceed both their in-house and overarching regulatory cold chain requirements. To achieve this, pharma companies are constantly looking for innovative products and services that can help them cost-effectively maintain the cold chain for temperature-sensitive products in transit on both a global and local basis.

Regulatory Compliance


Pharma companies face many challenges when shipping temperature-sensitive products, one of which is to ensure compliance with the various regional regulatory bodies. The introduction of Good Distribution Practice (GDP) guidelines in recent years, which have been implemented in Europe, requires a business to transport their products at strict label claim temperatures. Conversely, the FDA in North America allows pharma companies to transport their products using stability data that permits a wider range of temperatures during shipment.

At first glance, the GDP guideline and FDA requirements may appear quite similar, but, in fact, a difference exists between the two. For example, in Europe, a pharmaceutical product with a label claim that states the storage temperature as being between 2-8°C must be transported strictly within the stated ‘label claim’ temperature range. However, when shipping in North America, that same item can use known stability data to widen the allowable temperature range. For example, this means the same product can now be transported between 1-25°C and still meet local regulatory compliance.

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Clive Bryant is Senior Global Business Development Director at Softbox Systems and has more than 30 years’ experience of global cold chain and clinical trial logistics. Formerly Head of Life Sciences at DHL, he has been involved in developing innovative customer solutions that ensure cold chain maintenance and regulatory compliance.

Richard Wood is Technical Director at Softbox Systems and has been designing and engineering innovative temperature control packaging systems for the past 14 years. He has been involved in hundreds of global cold chain development projects working with a broad cross-section of the pharma and life sciences industries.
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Clive Bryant
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Richard Wood
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