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Serialization Challenges and Solutions: Integrating CMOs

Co-author and contributions by Megan Weldon

Over the next few years, global and multinational pharmaceutical companies will need to achieve and maintain compliance with multiple serialization regulations.  In the past, most have focused on implementing serialization capabilities at the enterprise, site, and line levels for their internal operations.  But as internal serialization capabilities mature, the focus is shifting to the integration of contract manufacturing partners into the serialization network.  Regardless of who physically packages and serializes the product, the entity with the legal right to bring the product to market is responsible for ensuring compliance.

Implementing serialization capabilities within an internal network introduces a handful of challenges on its own. By design, contract manufacturing organizations (CMOs) are their own separate entities, making the amount of control or oversight a Marketing Authorization Holder (MAH) can exercise somewhat limited. Below, I’ve outlined some of the key challenges we’ve encountered in our serialization work with recommended approaches for mitigating the associated risks.

Challenge: With requirements for upgrades or implementations from the line equipment to the L4 serialization solution, it’s difficult to find the right time to engage external parties.  And that’s only half the issue – the CMO must also be prepared and organized to begin exchanging serialized data.
Solution: Informally gauge your partner’s serialization readiness with a survey.  Based on your CMO’s results, you should be able to determine the sophistication of their serialization capabilities. Once responses are collected and analyzed, you can develop a high-level rollout strategy and execution plan.  Keep in mind, this plan is only a baseline and should be continuously monitored and adjusted.

Challenge:  The CMO is running product for multiple customers on one line with differing standards for each customer.
Solution: Before engaging with a CMO, it’s critical to have a clear understanding of the standards to which you will hold your partners.  Understanding your expectations at the onset allows for an efficient and productive engagement with your CMO. Bring your CMO partners into the conversation as soon as possible. Doing so gives you a greater degree of influence on the CMO’s standards impacting your products.

Challenge:  The United States serialization regulation, Drug Supply Chain Security Act (DSCSA), does not require aggregation to be implemented for the 2017 deadline. But many wholesalers are requesting aggregation sooner to reduce impacts to operational efficiencies.  As aggregation is not required for the near-term regulation, CMOs are pushing back on requests to provide aggregated products.
Solution: Again, establishing an understanding of expectations early on greatly benefits both entities. If the CMO is unable or unwilling to aggregate, the pharmaceutical company will need to identify an alternative path forward.  Potential solutions could include engaging 3PLs or utilizing internal facilities.

Challenge: Many regulations state that barcodes must be readable many years after the expiration date.  How can the MAH ensure the CMO is producing barcodes at a sufficient level of quality?
Solution: Set the barcode grade all products must receive before the product is shipped to the next supply chain partner.  American National Standards Institute (ANSI) and International Organization for Standardization (ISO) both provide guidance on acceptable barcode grades.  To ensure these grades are met, the existing quality agreement or manufacturing and supply agreement should be updated with verbiage on barcode grading.

The solutions outlined above are effective only because they’re based on a foundation of proper planning and clear, open communication – two absolute requisites when entering a contract partnership. As the life sciences industry continues to leverage contract relationships as a means for controlling costs, the ability to efficiently and effectively integrate new partners into your business model will define your ability to succeed.

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Tags: Serialization & Traceability
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