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Pharmaceutical Manufacturing and Packing Sourcer

Temperature-Controlled Distribution of Vaccines and High-Value Medicine

The cold chain encompasses all the storage and transport facilities necessary to ship a product requiring controlled low temperature storage from the manufacturer to the end user. Most biotechnology and pharmaceutical companies are structured globally and often have a complex supply chain. Pharmaceutical primary substances manufactured in one country are often shipped to a second country with a view to manufacturing bulk medicinal products.

This bulk medicinal product may be filled, labelled and packed in a final container in a third country from which it is shipped to the distributor, who may be situated in a fourth country. From the distributor, the medicinal product is sent to the end user, who may be located in a fifth country. When this complex supply chain must be temperature-controlled, the need for an effective and efficient cold chain becomes apparent. At every point in the cold chain, records have to be maintained to provide evidence of compliance with the labelled storage conditions.

At any given time of year, the distribution environment can vary greatly from country to country and even within the same country. The environment will also change significantly with the season. The International Committee on Harmonisation (ICH) has harmonised the stability testing requirements for medicinal products within three regions, namely Europe, Japan and the USA. Such harmonisation leads to harmonised labelling of storage conditions, which in turn leads to harmonised storage and shipping conditions. The advantage of such harmonisation lies in the fact that stability tests performed in one region are acceptable for the other two regions. Furthermore, medicinal products are treated in a consistent manner.


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By Tanja Leys, Marketing and Quality Manager at Dirk Raes NV

Tanja Leys is an Industrial Engineer at Dirk Raes NV, a transport company in Belgium specialised in temperature-controlled express deliveries across Europe and in the distribution of pharmaceutical products. Her thesis focused on the implementation of ISO-9002 for Dirk Raes NV. After five years' experience in a chemical company as a Reliability Engineer, she became Marketing and Quality Manager, a position she has held for the past four years.

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