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Johnson & Johnson COVID-19 vaccine contamination could have been avoided with traceability, monitoring of supply chain risk from procurement

04/06/2021 By

Mix-ups in supply chain and procurement happen. But when it’s a high-profile issue, like the recent Johnson & Johnson (J&J) Covid-19 vaccine mishap, it can make the general public distrustful and leave procurement professionals wanting to lend their expertise.

Although the mass vaccination effort is more of a focus for supply chain teams, it’s actually a great opportunity for procurement to step up and provide a way forward.

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Pharmaceutical procurement teams especially shook their heads at the handling of the J&J vaccine contamination when two recipes were accidentally combined. They know that these mistakes are fairly avoidable with a robust, digital-first solution.

TraceLink is one such solution. In a recent interview with Spend Matters, John Bermudez, the Vice President of Product Marketing at TraceLink, acknowledged that errors happen. But that’s where procurement can be a helpful arm to any organization focusing on pharmaceutical production.

“Mistakes are always possible, but the rigorous onboarding process typical in the pharmaceutical industry is designed to avoid the sloppy mistakes that were made in this case,” Bermudez said.

Last week, news circulated that a factory mix-up in a Baltimore plant led to up to 15 million doses of the Johnson & Johnson coronavirus vaccine to be contaminated. The plant was led by Emergent BioSolutions, a manufacturing partner for the J&J and AstraZeneca vaccines. Workers accidentally swapped ingredients for the two vaccines, affecting the shipment timeline of up to 24 million doses of the vaccine.

The J&J and AstraZeneca vaccines use the same technology (called a vector) that employs a version of the virus to help stimulate the immune system in people. But the two vaccines use a biologically different vector, meaning they can’t be interchanged. In February, one or more Emergent workers confused the two. This raised questions about Emergent’s hiring process and training, after it employed hundreds of new workers to help mass produce vaccines.

“The best practice is to track supplier compliance to all aspects of the production and quality processes,” Bermudez said. “This not only includes the expected quality checks of the vaccine, but also compliance with all good manufacturing practices, manufacturing processes specified for this vaccine, quality assurance processes, etc. By tracking supplier incidents at all levels, supplier management can identify poor performing suppliers and work with them to improve processes before something catastrophic happens — as it did with the J&J vaccine.”

But as the world awaits the vaccine rollout while fearing a fourth surge of Covid, any hiccup feels like a massive setback. The general public may raise an eyebrow and ask, “What happened there?” — but procurement experts are likely to think to themselves, “How can we make this process better?”

That answer lies in digitalization, clean and clear supplier onboarding, and having oversight into supply chains and traceability.

“Procurement teams are generally responsible for selecting and onboarding suppliers,” Bermudez said. “This is a rigorous process that can take up to one year for a CMO (contract manufacturing organization) like Emergent to produce a new drug. During this process called ‘tech transfer,’ every aspect of the supplier’s process and facilities are scrutinized. The usual scrutiny period was greatly reduced, and the Food and Drug Administration approved this facility for J&J and AstraZeneca use. This mistake likely could have been avoided with normal review processes in place to onboard a new supplier.”

When needing to act fast, it’s important that an organization look to as many areas as possible to help monitor risk. This is where procurement can step up to help organizations in supply-chain risk monitoring.

“Not all supply chain risk is a procurement responsibility — downstream risk generally falls on the Supply Chain Operations group. Procurement is responsible for vetting suppliers even when they are selected by other groups like Science and Technology,” Bermudez said. “This includes reviewing potential upstream risk at and beyond immediate suppliers to determine financial risk, geo-political risks, environmental risks and social responsibility risk. Supplier management not only needs to vet suppliers during the onboarding process but monitor their performance to spot potential risks that might be on the horizon. Building stronger relationships with suppliers can help mitigate risk by encouraging suppliers to report potential risks.”

Another key issue in J&J’s mishap was that Emergent’s mistake went uncovered for days before a J&J quality control check discovered it. Traceability, especially in pharmaceutical production, is another area where a procurement department can help an organization.

“Procurement is generally the point of contact for all supplier relationships and serialization (the beginning of traceability) is performed by the CMO that manufactures the product,” Bermudez said. “Actual follow up will be a cross-functional effort on both sides of the supplier relationship. Improved visibility and digital collaboration capabilities (like TraceLink Agile Process Teams) can greatly reduce the time to resolve a traceability issue.”

Digitalization may not be the be-all and end-all. People will still need to monitor things. But, the case study of the J&J vaccine contamination is more evidence that digitizing procurement operations can help speed up processes and allow for better products to get out the door. Not every mistake is dire, but when it comes to things like a mass vaccination effort, procurement really can mean life or death for thousands of consumers.

“Digitalization improves visibility, agility and joint decision making with suppliers,” Bermudez said. “With digital processes as those supported by TraceLink APT, both parties have visibility to ongoing processes like change requests, incident follow-up and exchange of updated standard operating procedures. Missing a change request or a change to a standard operating procedure could lead to a defective production lot or worse, such as a defective medicine that reaches patients.”

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