Traceability, that catchall phrase for the ability to track and trace products — whether batches, items or components — has been in use for many decades; so it’s not a new idea but is certainly something that interests all kinds of organizations, especially those making pharmaceuticals.
On the surface, traceability looks to be a common practice, but it has a long way to go — and much more can be done to ensure its use, level of penetration and ability to fulfill traceability goals, while also driving improved integrity of any organization’s complete supply chain. The importance of traceability at an item level only intensifies as legislators feel pressed to introduce laws for food, beverage and drug traceability that manufacturers have to abide by, including the 2015 requirements of The Drug Supply Chain Security Act (DSCSA).
REGULATORY LANDSCAPE
Serialization programs are complex and fluid. The regulatory landscape is by no means static, nor is it expected to remain so. Any organization selling products into these regulated markets can expect the requirements to continue evolving over a 10-year (or more) time frame. Serialization is not a one-off development, and companies are challenged to comply with serialization regulations successfully, effectively and quickly.
DEFINING TRACEABILITY
So, what exactly is traceability and why is it so important in pharmaceuticals? Let’s break it down:
With growth in e-commerce, traceability in the pharmaceutical supply chain is important. Why? To put it simply, there is a need to ensure companies get what they pay for and the safety of the product is assured. If a safety problem arises, traceability helps hone in on the product as a whole or as a batch, making it easier to recall. Robust traceability helps prevent fraud because distributors of counterfeit medicine are stopped in their tracks and prevented from profiting off fake products.
Counterfeit pharmaceuticals originating from Asia and the ease with which illegal vendors can use the Internet to sell is becoming a serious problem. Also, the availability of generic medication means consumers expect to get less expensive medicine. As the elderly population expands, it makes it easier for illegal and substandard products to enter the market and be sold through illegal outlets.
The Medicines and Healthcare Products Regulatory Agency (MHRA) says, “The World Health Organization (WHO) estimates that up to 1 percent of medicines available in the developed world are likely to be counterfeit. This figure rises to 10 percent globally, although in some developing countries they estimate one third of medicines are counterfeit.” Counterfeit medicine is more commonly available to consumers via online pharmacies. WHO estimates 50 percent of medicines available from websites that conceal their physical address are counterfeit.
TRACEABILITY SOLUTIONS
Consultancies can help offering traceability expertise through track-and-trace systems and applications using repeatable implementations to help pharma companies comply with mandates and leverage their track-and-trace solution to drive supply chain integrity.
In light of the current and future regulatory climate, it behooves companies to quickly adapt their IT systems, production, packaging lines and business processes in order to achieve compliance with the ever-growing list of regulatory requirements for tracking and tracing goods throughout the global supply chain. A quality track-and-trace solution can be implemented by any pharmaceutical company — at any point in the supply chain — faced with global regulatory requirements, regardless of the size of the business or current enterprise resource planning (ERP) system.
Pharmaceutical organizations looking to implement track-and-trace solutions should consider several elements. Traceability solutions should:
• Support all serialization and regulatory reporting requirements around the world (U.S. DQSA Title II, China, Turkey, Brazil, Argentina and more).
• Be easy to implement with minimal internal resources needed, and quickly achieve compliance with transaction information (TI), transaction statement (TS) and transaction history (TH).
• Achieve compliance with the DQSA Suspect Product Verification requirements.
• Be highly secure, fault-tolerant and operate via a high-availability SaaS platform.
• Run on a time-tested platform, such as SAP Track and Trace with SAP AII and SAP OER.
• Integrate with partners using industry standards.
• Enable compliance with regulatory requirements for computer systems, including GMP validation.
• Be a feature-rich serialization management and traceability solution — for example, one that includes multiple product identification formats.
• Offer an extensive standard report set.
• Offer 24/7 support resources.
The advantages of track and trace are clear. Serializing products at the item level and making them traceable offers pharmaceutical companies many benefits. The resulting transparency improves control of recall actions later, reduces shrinkage and measures marketing and sales strategies more effectively and efficiently. Track and trace offers businesses far more than assurances against counterfeiting and piracy. The decision to serialize and track products on an item level opens up a whole new range of options and supply chain transparency that can provide real value-added benefits for a business.
