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The rise of serialization regulation: What to know, what to do

June 1, 2015
What you need to know about serialization-based anti-counterfeiting regulations.
The rise of Internet pharmacies. Under-regulated wholesalers and repackagers. Advances in counterfeiting technology.

These are only a few of the opportunities that drug counterfeiters have seized upon in order to turn a profit at the expense of consumers’ health and manufacturers’ reputations.

As a result, a number of countries around the world are in the process of rolling out serialization-based anti-counterfeiting regulations. These include the European Union’s Falsified Medicines Directive, the United States’ Drug Supply Chain Security Act and China’s electronic drug supervision code requirement.

Here’s what you need to know.

The Basics

Serialization uses a numeric or alphanumeric code known as a unique identification (UID) to realize full track-and-trace capabilities of a product throughout the supply chain, from its manufacturing origin through distribution channels and down to the point of sale. Production, transportation and point-of-sale event information is recorded and stored in a central database. This allows a product to be authenticated as legitimate through something as simple as a quick barcode scan, and permits the complete product event history to be reviewed or audited should an issue arise.

While serialization regulations vary by country or region, some general requirements that pharmaceutical manufacturers are expected to comply with include:

  • The ability to generate, acquire and manage a UID for each saleable item.
  • Linking package-level serial numbers in parent/child data relationships (e.g., pallets to cases, cases to cartons or cartons to saleable items).
  • Storage of UID information in a secure database that can be shared with trading partners.
  • Validation that serialization data matches the physical product received.
  • Confirmation that products have complete and accurate documentation.

The Impact on Production

While governmental regulations lay out detailed requirements for what serialization systems must accomplish, they do not specify how pharmaceutical manufacturers should implement their serialization systems. This gives manufacturers some flexibility in their approach, but still leaves them facing a number of challenges.

On the operations side, pharmaceutical manufacturers have the task of trying to fully incorporate the serialization system into an existing control architecture that can include legacy equipment, multiple different device vendors, networks, protocols and proprietary platforms. A serialization solution must also be compatible with all package types and country-specific UID formatting requirements to ensure compliance and uninterrupted product changeovers. It should also support seamless integration of serialization components, such as high-speed printers and vision-inspection cameras.

There are also a variety of software-related challenges regarding the generation, integration and management of serialization data. Industry generally follows the ANSI/ISA-95 standard, which provides a four-level model for interfacing from the plant floor to the enterprise. Serialization-relevant data must be widely distributed over control and information systems across all four of these levels.

Generated UID numbers must be unique to the product, and it is best if they are random number sets versus consecutive numbers to help eliminate the likelihood of predictable UIDs. The system must be able to handle a large volume of data management to meet UID printing and verification demands in high-speed environments. Data must also be secure yet seamlessly integrated across multiple levels, from packaging and palletizing machines on the plant floor to manufacturing execution systems (MES) and enterprise resource planning (ERP) systems to a cloud-based event repository.

The Solutions

Some manufacturers may opt to develop their own customized serialization system in an effort to harmonize the system with their existing equipment and processes. But this black box approach can lead to support issues, parts shortages and knowledge-transfer problems in the long term. The time and effort needed to design, test and commission a custom system also can be costly and disruptive to operations.

Pharmaceutical manufacturers should instead consider basing their system on a modular and scalable off-the-shelf control and information platform that can be easily integrated into their existing lines. Specifically by tapping a software platform that also offers MES and electronic batch recording (EBR) capabilities, a serialization system can help address global serialization requirements, including necessary data capabilities and high-speed device management of serialization components—all while minimizing production interruptions or validation burdens.

Additionally, a serialization system that uses an Electronic Product Code Information Services (EPCIS)-certified, cloud-based server can provide centralized UID generation, management and storage, as well as ensure interoperability with manufacturing and business systems. The cloud-based server is the central communications hub for supply chain partners and provides mobile connectivity, so product authentication can flow all the way down to the consumer level via tablets or smartphones.

Other Considerations

Given the global nature of most pharmaceutical supply chains and the varying nature of serialization programs from one country to another, global support can be crucial to ensuring real-time and local-language assistance is available should an issue arise. Some manufacturers may also benefit from remote support services, which can help reduce the burdens placed on plant staff and be more cost- effective than transporting technicians from site to site. These services can include real-time, application-level support of serialization systems, remote-asset health monitoring and network design services.

It’s also important not to forget the silver lining of a comprehensive and holistic serialization system. Greater supply chain integrity offers more than compliance. It can also deliver reverse-logistics benefits, more accurate and efficient recalls and provide valuable data for improved forecasting and more customer-specific marketing programs.

So as you begin implementing serialization systems, don’t only focus on what the system must do. Start thinking about what the system can do.

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