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Industry Collaboration Sheds Light on Serialization

Serialization in pharma packaging is a complicated undertaking for anyone, but CMOs and their customers face additional challenges because responsibilities aren’t always clear-cut. A trend toward industry collaboration, even among competitors, is helping to shed light as companies share their successes and lessons learned.

Good things come to those who wait.

In the case of serialization in pharmaceutical packaging… yes and no. With little more than a year left to meet the 2017 U.S. deadline for manufacturer serialization, companies that haven’t started will be under immense pressure. But there is an upside for companies who have waited: they have opportunities to learn from others’ mistakes and success stories.

The industry is still brimming with confusion and fear regarding serialization, especially among CMOs who package products for many customers. In fact, a recent survey of CMOs found that 95% are afraid of losing business if they don’t comply.

To help foster collaboration, Optel Vision and Supply Chain Wizard recently held their first Serialization Roundtable for CMOs to encourage discussion between pharmaceutical manufacturers, CMOs, and vendors. The event creators urged attendees to remember that the regulations are ultimately about protecting people, their own families included.

CMO-specific challenges

The largest generic house in the world, Teva Pharmaceuticals, oversees production of 64 billion tablets/year and manages more than 700 CMOs. The company is well versed in evaluating serialization readiness. “You can’t wish your way to success,” said Vivian McCain, Teva’s VP of Third Party Operations, Americas, “You have to have a plan.”

The challenges of serialization projects for CMOs fall into three main buckets: financial, technical and operational.

The question of who will finance a CMO’s serialization efforts is truly the elephant in the room because the responsibility does not fall squarely on either the CMO or the pharma company. Dr. Evren Ozkaya, Founder and CEO of Supply Chain Wizard, said the CMO might pay for the upfront cost and then pass on a unit cost increase to the customer. He has also seen an increase in cases where the customer pays for serialization when the CMO has a dedicated line.

On the technical side, CMOs and customers must set up standards and come to agreements about responsibilities for packaging and label design. Both parties must ask whether they have the right resources, equipment and IT infrastructure, and there has to be discussion around how batches will be released, how exceptions will be managed, and who will store master data. Though there may be confusion about who owns the serial numbers, Supply Chain Wizard’s Priya Gopal clarified that the party that owns the product (i.e. the pharma company) should own the serial numbers, not the CMO.

In particular, McCain offered advice for CMOs who want to maintain or grow their market share:

There is communication hesitancy on both the CMO and customer sides. CMOs must be proactive in reaching out to pharma customers to ask about their requirements. If you don’t have internal resources to manage serialization, you have to get help. But there is a caveat: serialization service providers are limited in their capacity as well. And Ozkaya noted that internal serialization talent may be poached by other companies or may opt to start their own business, therefore getting outside help to ensure consistent support might be a good strategy for many.
Factor in time for efficiency losses. “You will lose efficiency when you do your pilots and upgrades,” said McCain. When I come into your shop to ask, ‘When will I get my product?’ I need to know you’ve factored that in and given a realistic date, because my customers need to know that when I make a promise, they are going to have it on that date.”

He also warned that there is often a gross underestimation of resources needed to manage the project, and that serialization should not be given as a development opportunity to a less-than-stellar employee.

Pilot projects

Experts and end users all agree that pilot studies are immensely important. Aladin Alkhawam, Director of Packaging Operations at PAR Pharmaceutical was on hand to educate attendees on rollout and pilot strategies and offer valuable lessons learned from PAR’s implementation:

Ensure testing is performed early on (ideally during Factory Acceptance Testing) for newly added printers. If functional or integration problems are discovered late, you may need to add addendum protocols to IOQ tests and/or replace the equipment.

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LAST CHANCE TO SAVE! New Tech for Life Sciences at PACK EXPO Southeast