Pharmaceutical Serialization Makes Sense for Product Tracking and Traceability

Counterfeit drugs harm or kill millions around the world and inflict serious damage on the brand names and bottom lines of major pharmaceutical manufacturers. According to industry estimates, sales of counterfeit pharmaceuticals are estimated at US$163 billion to $217 billion. Developing markets were once the main targets for counterfeiters but now, digital channels are being used to traffic counterfeit pharmaceuticals around the globe.

As global regulations aimed at protecting public health, intellectual property and national security tighten, many countries around the world have introduced track and trace laws to help regulate pharmaceutical products as it passes through the supply chain. The track and trace system and serialization are widely used among all anticounterfeit technologies in different countries.

Whether you are a pharmaceutical, medical device or consumer packaged-goods manufacturer you are now required to track and trace products across the supply chain.

Why is Serialization Important?

Over the next few years, global mandates will require manufacturers to exchange transaction information in an interoperable electronic manner. In the United States, The Drug Quality and Security Act will be in effect by 2023; The ANVISA regulations will be enforced in Brazil by 2020; The European Falsified Medicines Directive is currently being implemented throughout 2019; while in China, the China Food and Drug Administration Regulations are currently in effect.

Taken together, more than 75 percent of the world’s prescription medication will be protected by legislation by the end of 2019. 

To date, only production-related information, such as the expiration date and lot codes, has been printed on products and their final packaging. However, serialization – the application of a unique alpha or numeric identifier on every pharmaceutical package down to the unit level of sale – is a common requirement among the otherwise disparate international initiatives scheduled to take effect in the next few years.

These unique identifiers must be stored in a database along with other information about the item, including manufacturer and batch details. Using unique serial numbers, the authenticity of items can be verified against the database at every step in the distribution chain, from the manufacturer to the consumer.

Thankfully, the ability to have a solution that includes real-time visibility, ISA-95 certification, while meeting pharmaceutical serialization requirements is now possible.

A Holistic Approach to Product Tracking and Traceability

Global pharmaceutical companies lose an estimated $75 billion annually to counterfeit, grey market and stolen product. To help combat this, the Rockwell Automation serialization solution takes a holistic approach to product tracking and traceability – providing a single approach to address regulations, product counterfeiting, and recalls.

The solution is built on industry standards (IEC 61131, ANSI/ISA-88, ANSI/ISA-95) and uses open network and communication protocols, and commercial off-the-shelf technologies, eliminating the need for black-box proprietary control solutions and the associated custom interfaces and custom drivers that they require.

This open approach gives both OEMs and end users a single solution to address current and upcoming regulations, product counterfeiting and product recalls for the pharmaceutical industry. It can be a complete turnkey solution, from packaging to MES to ERP to Cloud or a scalable solution to where your current needs are today.

The Rockwell Automation Solution delivers five key benefits to pharmaceutical manufacturers:

1. Scalable, Flexible, Customizable: The global solution is scalable to provide design, delivery and long-term service and support, and is fully compliant with GS1 standards. The solution is scalable to meet the needs of any customer — from small-scale solutions for OEMS to full-scale, end-to-end solutions to help adapt to changing requirements and withstand company growth.
2. Seamless Interoperability: Interoperability among all machine devices, control systems, manufacturing execution systems, and information and business systems
3. Centralized Data Management: Data management is critical for current operations and for extra layers of information regulatory compliance requires
4. Full Traceability: Traceability is required in operations across the entire supply chain, from manufacturing and distribution, to point of dispense
5. Common Data for Actionable Intelligence: Access to real time insights helps manufacturers minimize business risk, comply with regulations and protect their investment

Pharma Company uses Serialization to Produce Life-Saving Medicines

One of Asia’s largest biopharmaceutical companies is driven by the vision to improve access to high-quality, life-saving biotherapeutics. They needed a turnkey serialization solution with complete track and trace technology to secure and authenticate products across its supply chain.

Rockwell Automation delivered a serialization solution that addresses challenges across the spectrum, from automation to MES and ERP to the cloud.

The FactoryTalk ProductionCentre solution integrates quality management and business analytics with a paperless shop floor and repair execution. This improves operational efficiencies while sustaining regulatory compliance and the highest level of quality. Rockwell Software PharmaSuite offers an innovative approach to serialization, with role-based optimization at each stage of the recipe lifecycle that drives time to results. Open-content architecture paired with an intelligent upgrade engine provided a powerful system designed for growth in both batch and discrete processing.

Using commercial off-the-shelf (COTS) hardware and software that’s modular, scalable and reusable, the solution accommodates manual packaging lines with a pre-validated, optimized tool that supports manual serialization and aggregation workflow. It meets global standards to enable quicker production restarts with an integrated, open network and communication standards from device (printing, vision and scanning) to the enterprise level.

Adaptable on a global scale to meet current and future regulations, the enhanced system can adapt to more packaging line technologies and production management systems providing a more scalable solution.

This enhanced serialization enabled the pharma company to achieve 100 percent U.S. Food and Drug Administration (FDA) and European (EU) regulatory compliance. The solution has reduced: Packaging rejection from 7 percent to less than 1 percent; cycle time by 18-29 days; and work in progress by 5 percent.  In addition, the lines are now paperless with end-to-end supply chain traceability.