What is Serialization?
Serialization is the assigning a product identifier to each product item to be tracked and traced to its location in the supply chain. 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 description, stock-keeping unit (SKU), lot or batch number, expiration date, date of production, and line and plant in which it was manufactured.
Changes in regulations by leading bodies such as US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have increased the significance of regulatory compliance management for finished prescription products. Pharma companies across the globe are need alter their practices to comply with regulations and anti-corruption laws. Until now pharmaceutical companies have been battling counterfeit drugs. These challenges have been from improper branding to hiding safety information and not following quality manufacturing standards. This caused regulators to add more laws and procedures to help protect consumers unsafe drugs.
Value Beyond Compliance
1. Brand Protection – Serialization helps protect consumer safety through proper labeling management of packaging processes. This can help protect brand reputation by increasing patient safety.
2. Visibility in the Supply Chain – Manufacturers can capture necessary information while a product moves through the supply chain. Companies can improve efficiency, control costs, and increase shipping accuracy.
3. Increase Profits
How to serialize
1. At the pallet level – wholesaler
2. At the multipack level – wholesaler/retailer
3. At the single pack level – hospital pharmacy level
Serialization with rfxcel
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.
Flexibility in a partner
To succeed in serialization, solution provider should be flexible and understand the customer’s environment to customize a solution to fit. A serialization solution is never “one-size-fits-all” because every company is different. The right partner 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.
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