Over the last four decades, supply chains have gone from being measured in meters to miles – and ultimately to continents & hemispheres.
Without a doubt, drug industry globalization has been a key factor in our success here at Neuland. But it has also spawned a range of supply chain anxieties – quality concerns, thorny compliance & regulatory issues, increased threats of supply disruption, growing (and waning) trade worries, and more.
It’s no wonder pharmaceutical supply chains have become such a hot topic of late. January saw topical articles at ContractPharma, Pharmtech, European Pharmaceutical Review, Industry Week and elsewhere. It feels like supply chains are practically everywhere. Which – of course – they are.
Global Supply Chain Complexity
Today, a drug supply chain can stretch across numerous countries on multiple continents, sometimes moving back and forth. A drug may cross multiple borders – from research and discovery across Europe, Japan, North America and elsewhere, to manufacturing supply chains running from China to India and then onward, to distribution around the world.
Supply chains – while increasingly complex – are growing increasingly secure.
Are we there yet?
No, but we have made great strides. Many of our advances towards supply chain security can likely be traced to the increasing global standardization and harmonization of industry practices and regulations across borders – enabling streamlined compliance with multiple jurisdictions.
We’ve discussed standardization & harmonization efforts here on the blog in the context of the U.S.-E.U. Mutual Recognition Agreement, ICH Q12, and the Revised FDA CDER SSM. These and other industry changes are helping (or hopefully will help) to tear down borders and restructure how the industry operates.
Supply Chain Security Steps
Challenges certainly remain, though.
Supply chains may be more secure, but they aren’t (and perhaps won’t ever be) 100% fully secure. Pharma industry suppliers like Neuland are increasingly taking steps to ensure the security of their own supply chains. (In our case, we’ve adopted backward integration practices, and have established redundant manufacturing facilities to ensure continuity of supply.)
The introduction of Quality By Design, DoE as well as many other new practices and procedures in recent years have already aided in reducing the risk of manufacturing-related supply chain interruptions. But quality and compliance problems still arise around the world – highlighting the continued importance of selecting an outsourced pharma contract partner with a proven regulatory track record.
Serialization – a key step towards supply chain security – is still a relatively new art. It will certainly evolve up and down the supply chain in the coming years…both as our capabilities extend, and in response to future emerging threats or practices.
Macro challenges also exist (and will always continue to exist). These include environmental, trade and government-related supply chain uncertainties, all of which seem to have become hot-button topics for the drug industry in recent years.
The last few years have seen plant shutdowns due to pollution and emissions, government-ordered shutdowns due to construction, and the sudden threat of cross-border tariffs – all of which can impact pharma supply chain risk management.
On the Plus Side…
When you consider the relatively short span of time in which drug supply chains have evolved, the impacts have been tremendous. As mentioned earlier, a typical drug is likely to cross multiple borders in its path to market – an astounding logistics feat when compared to just 20 or 30 years ago.
Supply Chain Security Has ‘Joined the Ranks’
With shifting regulatory landscapes, ever-present global challenges and increasingly complex chemistry- & quality-related issues, supply chain security has risen to become a prominent issue in pharma boardrooms over the last decade. Now that it’s top-of-mind, it’s likely to remain a top consideration in the years to come as companies seek to proactively manage risk.
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