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Confronting Global API Supply Chain Challenges

Lately, I’ve been thinking about the subject of global API supply chain challenges. There have been a few articles recently, but it isn’t a new topic. Global drug supply chain concerns have been around for quite a while, but instead of fading, their importance continues to grow.

It’s a topic that was front and center at DCAT this year, as Rita Peters reported at PharmTech:

“At the annual gathering of the Drug, Chemical and Associated Technologies (DCAT) organization in New York City in mid-March 2016, representatives of pharma companies and industry suppliers examined shifts in sourcing of APIs and the business drivers behind the changes. They also heard cautionary advice about regulatory challenges for drug companies involved in global sourcing…”

There’s no doubt that globalization of the drug trade has led to supply chain issues, typically involving regulatory compliance issues (which remain regionalized, not globalized).global

Neuland – which sits upstream of drug companies and possesses a global supply chain itself – faces similar challenges. Our solution is to demand the same thing from our supply chain that our customers demand from us: transparency, uncompromising adherence to relevant quality standards and strong, open communication and data-sharing.

One way in which we do this is by building stringent controls in our workflow. We monitor & document every activity – from order processing and procurement of materials, to final shipment of the consignment to the customers.

Our facilities (and our team members) are compliance-obsessed: we continuously monitor adherence to cGMP guidelines [ICH (Q7)] as well as the various requirements of FDA, ICH, EMEA and EDQM in our two manufacturing units.

Who’s Responsible for Drug Quality?

The big regulatory “shift” in supplier-sponsor relationships – in which the supply chain quality burden shifts to the drug company – isn’t (in my opinion, at least) that big a shift at all. Drug companies should always be cognizant of and involved in the quality of their products. Likewise, so should their suppliers…and onward up the supply chain. The burden may have shifted on paper, but when it comes to supply chain quality, smart companies have always been on point.

Drugs: Cheap…and Sometimes Compliant
In the PharmTech article I mentioned above, Peters closes:

“For drug license holders, quality, compliance, and monitoring need to be factored with product price when selecting and evaluating API suppliers for the long term.”

It’s solid, unambiguous advice. Cheapest is not always best, especially when it comes to API suppliers spread around the world.

I’ve had too many conversations to count in which I essentially tell people why they sometimes have to pay more to get less of the undesirable outcomes:

  • No out-of-specs
  • No missing documentation or paper trails
  • No warning letters from the FDA
  • No patient-safety issues
  • No surprises.

 

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