Haris Kamal is senior vice-president of Verify Brand.

Haris Kamal

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.

	Assess near- and long-term data requirements

	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:

		Commissioning (applying the serial number to the product), packing, and shipping. These events provide the data needed to comply with DSCSA.

		Other processes that occur in the normal flow: unpacking/repacking, rework, sampling, inspection, and more. Every business is different, so carefully assess current processes and consider where visibility into those processes could yield useful business intelligence.

		Exception processing, including reverse logistics.

	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:

		Reporting the right data to downstream trading partners for DSCSA compliance

		Supporting an investigation if there is suspicion that the supply chain has been compromised

		Answering ad hoc queries in support of day-to-day business operations. For example: which serial numbers are in this shipment? Which item-level serial numbers were packed into this case? When was this returned carton originally shipped, and do the serial numbers match?

	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:

		Exactly what critical, tracking-event data do they expect to receive? Then consider how this compares to the data you plan to capture and make adjustments as necessary.

		Is there agreement on the identifiers to be used in the data? For example, are all parties using Serialized Global Trade Item Numbers (SGTIN) for product identification and Global Location Numbers (GLN) for party and location identification?

		What master data need to be synchronized with each partner? Required master data might include trade item attributes, such as drug name, dosage form, and dose. Required party and location master data usually include name and address information.

	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:

		In what format do trading partners expect to send or receive data? Will that data be compliant with the latest GS1 EPCIS standards, including the GS1 US guideline for the use of EPCIS in the US pharmaceutical supply chain? If not, what is the partner’s plan for complying with those standards?

		What mechanism will be used to transmit or receive data? Understand the risks and benefits of each approach, including any additional costs and resource requirements to support legacy protocols like Secure File Transfer Protocol (SFTP) and Applicability Statement 2 (AS2).

		What are the security requirements for data exchange with each trading partner?

		Are all partners ready to handle data exchange at full scale for both near term and long term? Will this be confirmed through at-scale testing prior to going live?

	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:

		Will the vendor partner analyze your business processes and ensure that the right data are collected and can be used most effectively? What evidence can they provide of having done this for other companies, both within and outside of the pharma segment?

		Is the vendor compliant with the latest GS1 EPCIS standards, including the GS1 US guideline for the use of EPCIS in the US pharmaceutical supply chain? Be sure to verify this by getting data samples and having them verified by an expert.

		While it’s critical to find a vendor that can provide quick and efficient implementation now, find out how the vendor can leverage your serialization platform for business insights and smarter supply-chain operations down the road.

	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:

		Does the vendor have the sales, support, and engineering capacity to support your company adequately? As other companies rush to meet the compliance deadlines, will the vendor be overwhelmed? Will the vendor be able to grow as your company’s needs grow?

		What experience does the vendor have supporting serialization for companies comparable in size, geography, and type of business?

		Is the vendor already working with your trading partners? If not, are they capable of interfacing with the systems your partners use?

		What will be the total cost of ownership for the serialization solution? Does the vendor understand all components of total cost? Are there any hidden costs for future connectivity?

		If you need to switch to a different vendor, what will the process be for transferring data and cutting over operations? Consider both voluntary scenarios and involuntary scenarios (e.g., the vendor goes out of business).

	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.

	When referring to this article, please cite it as H. Kamal "Serialization Preparation Prompts Data and Business Questions," 

Pharmaceutical Technology, Partnerships in Outsourcing Supplement

Articles

As the date for implementation of the Drug Supply Chain Security Act approaches, bio/pharma companies and contractors should focus on key areas.