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As the date for implementation of the Drug Supply Chain Security Act approaches, bio/pharma companies and contractors should focus on key areas.
November 2017 deadlines for complying with the Drug Supply Chain Security Act (DSCSA) are right around the corner. As the industry prepares and plans, each company is in a different stage of decision-making and serialization implementation. While the top priority is on compliance, other factors should be considered when choosing a serialization platform.
DSCSA labeling and reporting requirements should take priority, but getting the right serialization solution in place quickly should not mean ignoring opportunities to boost revenue and optimize business processes. Bio/pharm organizations that assess both immediate compliance needs and flexibility, scalability, rich data, and business insight requirements for the future can achieve both short- and long-term goals, and create a solid foundation for growth and enhancements.
The potential for future value generation from serialization is directly a function of the data captured, specifically the critical tracking events in the life of a product as it moves through the business. To maximize value, consider all the business process steps for data capture, including:
All critical tracking events should include the basic four dimensions: what (which serial numbers are involved); when (date/time, including time zone); where (location); and why (the business context including the process step, condition of the products, and associated business transactions).
The value of capturing the correct data is revealed when an organization can query the data and use it in business operations for applications such as:
Pharma manufacturers, contract manufacturers (CMOs) and re-packagers, and third-party logistics (3PL) providers and distributors all have a responsibility to ensure traceability of products within their operations. Each trading partner will expect to receive data derived from the tracking events a pharma company captures within its walls. Conversely, the pharma company may need to accept or receive data from a supplier.
The most important thing to understand is the content of the data that needs to be exchanged with trading partners. Questions to ask partners include:
Partners may also be at an early stage of understanding their own requirements, so be sure to dig deeply and question whether partners are providing all the necessary detail so there are no surprises as the deployment deadline gets closer.
After agreeing on data content, there are many more technical issues that have to be addressed to achieve smooth interoperability with partners. A common theme is adherence to widely accepted industry standards, especially when interfacing with multiple partners. Consider these factors and include them in partner discussions:
It is important to demonstrate through testing that IT systems and partner systems will interoperate. With limited time left to implement and test systems, the more that can be prepared ahead of time by understanding the systems involved, the faster the project can get to the testing stage.
It takes time to implement serialization and ensure that the necessary trading partner connections support the exchange of supply-chain data. Once company data requirements have been assessed and the trading partner requirements have been confirmed, vendor criteria can be determined.
Some of the important vendor evaluation criteria that flow from business requirements include:
Equally important are questions about the vendor’s capacity to be a trusted partner, both in the short and long term. Look beyond whether a vendor’s solution meets all of data and technical requirements to whether the vendor itself is a good business fit:
Above all, it is important to recognize the strategic importance of serialization. Compliance with the November 2017 DSCSA guideline may be the motivating force today, but that is just the tip of the iceberg. Serialization is the foundation for knowing exactly where a product is through all steps of its lifetime. Laying a solid foundation now will provide benefits for many years to come.
Pharmaceutical TechnologyPartnerships in Outsourcing Supplement 2017
When referring to this article, please cite it as H. Kamal "Serialization Preparation Prompts Data and Business Questions," Pharmaceutical Technology, Partnerships in Outsourcing Supplement 2017.