Serialization is the assigning of a predetermined coding type to each product item, assigning it with a distinct identity to be tracked and traced to its location in the supply chain or where it had been in during its life cycle. A serialization code can be as detailed as a customer or government regulation requires and can include the manufacturer’s Global Trade Identification Number (GTIN), product or drug description, stock-keeping unit (SKU), lot or batch number, expiration date, date of production, and line and plant in which it was manufactured.
Many solutions offer flexibility built into the code structure with application identifiers (Als). The GS1 standard, a system of global standards, has defined AIs in a way that allows for a significant amount of information to be included in the code.
Why serialization?
Compliance:
Changes in regulations by leading bodies such as US Food and Drug Administration (USFDA) and the European Medicines Agency (EMA) have increased the significance of regulatory compliance management for finished products. Pharma companies across the globe are compelled to alter their compliance practices to conform to changes in regulations and stringent anti-corruption laws. Historically pharmaceutical industry has been dealing with malpractices across the value chain ranging from improper branding to masking safety information and disregarding quality manufacturing standards. This has led to regulators keeping a strict watch on the pharma companies. Enforcement agencies the world over have become more active. Any violation of regulatory methods or non-compliance of standards could tarnish a company’s reputation, risking its future.
To help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. Accurate serialization will improve and remove counterfeit drugs. Click & Tweet!
Value Beyond Compliance
- Brand Reputation
A serialization investment can deliver numerous benefits for manufacturers.serialization helps protect consumer safety through proper labeling management of packaging processes. This can help protect brand reputation by increasing patient safety.
- Visibility in the Supply Chain
understanding of the supply chain process, it can more easily control inventory and drive better understanding of the impact of disruptions.With serialization, manufacturers can capture necessary information while a product moves through the supply chain. This enables them to improve efficiency, control costs, and increase shipping accuracy, ensuring recall integrity
- Profits
According to the World Health Organization, an estimated 10 to 15% of the world’s drug supply is counterfeit, and billions of dollars are lost each year as a result. With counterfeiting having such a profound effect on the bottom line, many companies agree that it can only be addressed through multiple layers of security including specialty closure devices on packaging, security tapes, specialty inks, forensic materials in packaging, smart codes, and other dynamic variables to verify authenticity. Yet, serialization is the main key to transparency along the supply chain, enabling true track-and-trace capabilities. Serialization makes it difficult for counterfeiters to duplicate valid codes and can minimize risk to consumers and improve consumer safety.
How to serialize
- At the pallet level: It is possible to track and trace operations at a logistics center level (wholesaler).
- At the multipack level: It is possible to track and trace operations at a distribution center level (wholesaler/retailer).
- At the single pack level: It is possible to track and trace operations at a hospital pharmacy level.
- At the vial level: It is possible to track and trace operations at the level of the point of use of the drug.
Our 13 years of experience implementing serialization and track and trace solutions enables us to offer excellent service in projects undertaken for customers. With well-integrated technologies and systems, rfXcel is ready to reap the continued benefits of Track & Trace and deliver similar capabilities to its partners.
Serialization adoption
The biggest issue with serialization adoption by pharmaceutical manufacturers is the infrastructure required to support it. Serialized codes need to be managed throughout the entire supply chain from manufacture to distribution, and ultimately scanned at the point of dispensing. After the code is scanned at the point of sale, the information is sent to an interoperable management site, a system that electronically manages all the e-pedigree transaction information. This becomes a big undertaking for manufacturers and supply chain partners not only because of the ample amount of information that needs to be managed and the impact on the production and throughput processes, but also because the costs associated with implementation and management of such a system can be substantial. Customers are unaware of the financial benefits of implementing a serialization solution and, therefore, find it hard to make an investment in something that is still evolving.
Flexibility in a partner
To succeed in serialization implementation, companies should work with a flexible partner that can customize a solution to fit their needs. A serialization solution is never “one-size-fits-all” because every company’s are different. Click & Tweet! The right partners will offer track-and-trace capabilities and software components designed to address requirements for the pharmaceutical industry, and can customize the offering for virtually each track-and-trace project addressed. Additionally, it is beneficial to identify partners that have the capability to manage the entire packaging/process and keep track of the data across the supply chain.
