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The Cure for Meeting Pharma Requirements

Complying with global pharmaceutical serialization and traceability regulations without collaboration and system interoperability represents a significant challenge for pharmaceutical trading partners.

Collaboration preempts disagreements among supply chain trading partners simply because complete, accurate data is important to both parties. Contract manufacturing organizations (CMOs) are a crucial component of the pharma manufacturing ecosystem, and many pharmaceutical companies depend on them.

Pharmaceuticals companies need to collaborate closely with their CMO partners on serialization to avoid compliance-related supply chain disruptions. At the same time, CMOs need to collaborate with the rest of their trading partners to prevent shipping and distribution issues.

Interoperability is crucial for installation, integration, and support for any company producing licensed products to achieve seamless compliance with the new serialization requirements.

The most challenging aspects of serialization projects are financial, technical, and operational. Collaboration from a financial perspective means understanding who will pay for the integrations. Talk to your partners about alternatives and choose a win-win option.

From a technical perspective, CMOs and customers must set up standards and agree on responsibilities for serial number standards, packaging, and label design. It’s also important to ask whether parties have the right resources, equipment, and IT infrastructure.

On the operational side, companies underestimate how time-consuming serialization is. It’s not only the initial integration but also maintaining the system as your companies grow. CMOs, CPOs, and other vendors should discuss this from the very beginning.

BENEFITS OF COLLABORATION

Aligning and collaborating within an established framework and processes ensures that the solution works seamlessly across organizational boundaries. Additionally, it is easier to validate systems and focus on data quality. And normalizing or correcting data has to be done before it is pushed further to other systems to avoid damage.

Collaboration among pharmaceutical manufacturers, CMOs, and trading partners will also boost serialization capabilities for better forecasts and decision-making. The detail in data that serialization brings can decrease the loss in product returns in situations when customers buy a product at a discount, and return it at full price. Companies can track the purchase price at unit level to avoid these situations.

The good news: Many solution providers offer integration-as-a-service as part of their software product; they have the ability and expert IT personnel to integrate systems and deliver ongoing technical support. Offering an integration service in addition to the solution keeps costs low by defining a framework, processes, and costs upfront.

Collaboration and system interoperability can help the pharmaceutical industry streamline the serialization process in the supply chain.

Jack Tarkoff, Chief Strategy Officer