Investigative reporting can include unconventional tactics to get sources to speak more openly.
I used this on Carlos Machado, serialization specialist at SEAVision, despite Machado’s already providing Outsourced Pharma with valuable information on DSCSA, resulting in editorials titled, Riding With The Drug "Serializers" Of Pharma, and most recently, 6 Months To Serialization: A Review And Projection.
“It’s springtime 2019,” I began. “You’re relaxing with a cold beer, reminiscing over the past few years and those final months getting drug sponsors and packaging providers compliant with FDA requirements for the first stage of serialization … What will have most surprised you?”
This sets Machado back a moment (perhaps contemplating the leisure time as much as the serialization review).
“If I were to sum it up,” he says, “what surprises me the most was the lack of urgency from many customers [biopharma companies]. I just don’t think these organizations put enough stock into what the FDA was actually asking them to do.”
Machado made clear in our recent article this behavior was exhibited specifically by smaller drug sponsors. Some of the behavior stemmed from a “lack of self-education” regarding the efforts needed, and because reaching for outside help would incur costs and time-loss less easy to accept than at more established companies.
Nonetheless, as we stand six months away from the final deadline for item-line serialization, Machado is sanguine regarding the vast majority of companies making it successfully to the finish line.
“I think it will be fine for those with product already distributed in the U.S. If there’s an organization with a product that runs across different lines, if they don’t have all the lines serialized, they will increase production on a line that is. I’d say 90-plus percent delivering product to the US are going to be in a good place.”
“There may be some production run delays or other adjustments if necessary,” adds Machado. “They’ll figure it out. These companies were smart enough to get where they are today; they’ll be able to figure out how to move forward.”
Moving forward, though, will include entering the next leg in the serialization race: full aggregation of drug product.
A More Serious Aggregation
Comparatively, this next level of U.S. serialization hasn’t received the attention heaped on phase one. The FDA defines aggregation as “the process of building a relationship between unique identifiers assigned to packaging containers.” (A fuller description from the FDA below.)
So while item-level serialization is fundamentally about labeling a single unit of sale – say an individual carton – aggregation is then taking that individual unit and tracing it to the larger bundle, case, and/or pallet it came from. This forms a child-to-parent relationship. For example, two dozen individually serialized cartons are now aggregated to a single case they were all taken from.
“Then, taking it a step further,” explains Machado, “you can aggregate that case to a palette of cases. That palette becomes the grandparent, so to speak. I can scan that palette label, and see every individual case that’s there, and also the layer down, to the individual items within. The first requirement was item level; this second phase is full aggregation.”
The good news is that quite a number of biopharma companies undertook full aggregation implementation as they were making the initial efforts for phase one serialization.
However, for everyone selling drugs in the U.S., there is a new deadline to meet: November 2023. That’s another five years for what should result in a more traceable and trustworthy drug supply chain. Should something go amiss anywhere along that supply chain, getting to the root of the matter, and getting product out of the chain, will be done safely and effectively.
An Improved Prognosis
Despite accurately predicting way back in 2016 that the FDA would have to delay its initial serialization deadline of November 2017, at this point in time Machado anticipates no such need once November 2023 rolls in.
Why? “Everybody understands the requirements this time, and really how to implement the aggregation side. It’s not new technology. Moreover, many companies have already implemented aggregation. The demand will naturally be minimal in comparison to the initial wave of human resources and equipment needed for implementations.”
In fact, over the coming months and years, Machado envisions as many business opportunities as challenges. For example, a contract manufacturer with serialized lines for syringes, or various types of carton sizes, can differentiate itself to drug owners. And since we can certainly assume that biopharma – emerging and established – will always be looking to add or develop new technologies throughout the supply chain, the entire industry should advance partly on the back of serialization solutions.
End At The Beginning
Finally, let’s end our two-part look at serialization back at the FDA, and what the agency specifically mandated for this ultimate goal of traceability by November of 2023.
The “critical steps to build an electronic, interoperable system for enhanced drug distribution” are outlined within the “Enhanced Drug Distribution Security (EDDS) phase mandated by the Drug Supply Chain Security Act (DSCSA).”
Here are those established requirements laid out:
For many, right after that break for a little relaxation we envisioned above with Machado, it’ll be right back to work.
Past articles on serialization by Chief Editor Louis Garguilo:
6 Months To Serialization: A Review And Projection
Drug Serialization Reaching Consumers
Biopharma Climbs The Serialization Mountain
GSK’s Global Strategy For Serialization
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