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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.

Overall, pharma logistics lag behind other industries. For instance, the processes and technologies developed by the hi-tech industry are only now being adopted by the pharmaceutical industry; hi-tech has been using real-time GPS technology for years and pharma is only now beginning to catch up.

I do think the key to success for pharma is collaboration; and it’s great to see the industry improving in that regard. We now see pharmaceutical shippers using the supply chain as the forum for collaboration – this may be in part due to the introduction of the EU GDP guidelines, which puts the emphasis and responsibility on the shipper to ensure that their supply chain is compliant. The only real way of doing this is to communicate with all of the stakeholders, and develop and implement quality agreements and standard operating procedures with all parties.

We are also seeing greater emphasis on outsourcing and, in particular, the use of external supply chain expertise. Developing, monitoring and maintaining processes that are compliant with all major regulatory bodies involved is a crucial task – and it may be beyond the scope of those already employed within a company. Rather than trying to train employees to carry out such duties beyond their current role – or creating a new permanent position within the firm – outsourcing to an independent consultant can be an efficient and cost-effective option. Furthermore, where the supply chain transcends national regulations by crossing international borders, having a local expert for each area traversed is crucial.

I am hoping that the industry will continue to work towards global best practice standards, using GDP guidelines that provide a solid quality system for the movement of pharmaceuticals. Companies need to recognize that investment in strong logistics partners is crucial. Setting up compliant supply chains to avoid damage to products (and the resulting claims) is a better long-term solution for the industry; driving down the price of logistics spend should no longer be the focus.

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