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Pharmaceutical Manufacturing and Packing Sourcer

Stamp of Approval

Over the past 10 years, Good Distribution Practice (GDP) has become something of a buzzword when discussing best practice within the pharmaceutical logistics industry. However, a vast amount of confusion remains over its meaning, especially when it comes to which guidelines and licenses apply to each part of the supply chain.

Part of the problem lies in the fact that there is no single global standard. While the WHO provides global guidance, 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.

However, it is interesting to note that, within the US Pharmacopeia (USP), which provides guidance to the US pharma industry, there has been a significant focus on supply chain security, with less emphasis on GDP as a whole. This is currently being reviewed, with the revision of Chapter 1079, in line with the introduction of the Drug Quality and Security Act (DQSA), sometimes referred to as ‘track-and-trace’. The DQSA means that supply chain integrity and GDP compliance within the US are now being addressed by the FDA, and it is the USP’s goal to provide supplementary clarification and guidance on the requirements set out in the DQSA (1).

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Amy Shortman has 20 years’ experience within pharma and healthcare logistics. During this time, she has worked in operations, sales, and business development. In 2011, Amy founded ASC Associates to fulfil the increasing demand for expertise in compliant and secure supply chains and has since developed a global team of experts that can advise, support, and connect teams throughout the entire supply chain. She also works with IATA as an External Instructor for CEIV and is a Chartered Fellow of The Institute of Logistics and Transport, UK.  

Henry Moran has over 20 years’ experience within the logistics industry, having worked in numerous roles in hi-tech electronics, global logistics, and freight forwarding. Additionally, he has a master’s in business studies, specialising in manufacturing and logistics and is a practising six sigma black belt. Henry now focuses on supporting clients to assess, secure, and develop compliant supply chains through his work with ASC Associates.

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Amy Shortman
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Henry Moran
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