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Manufacture Business Practice, Small Molecules, Trends & Forecasts

Compliance and Collaboration

I have been involved in shipping pharmaceutical products for the past 21 years. During this time, there have been gradual and slow improvements, largely brought about through regulatory changes. The most significant changes have been influenced by the EU GDP Guidelines. These “new” guidelines were issued in 2013 and they changed the way the industry, certainly within logistics, handles pharmaceutical shipments.

But there still seems to be a great deal of confusion across the world when it comes to working out which guidelines and licenses apply to each part of the supply chain. Part of the problem comes down to the fact that there is no single global standard. The World Health Organization provides global guidance, but the levels of GDP compliance vary significantly across the world; each country has its own interpretation of exactly what GDP entails, and these are usually influenced by one of three regions: the EU, US, and the rest of the world. Generally speaking, the more advanced the country, the more comprehensive the GDP guidelines will be.

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