In nearly every industry, supply chain traceability is an inescapable requirement. Modern distribution networks are vast and far-reaching, with products often crossing international boundaries and arriving at multiple facilities before eventually reaching a final destination. Given the complexity of these networks, supply chain operators often require their manufacturing partners to outfit products and shipping cartons with fully traceable markings like barcodes, data matrices, and batch numbers.
Although these requirements are shared across industries, they are especially important for those involved in pharmaceutical development and packaging. As one of the most regulated industries in the United States, pharmaceutical companies need to follow several important labeling laws or incur steep fines, expensive recalls, and reputation-damaging news stories.
Fortunately, by using quality marking equipment and following best practices, companies can create complete traceability in the pharmaceutical industry and avoid distribution troubles. These three steps are a great way to start:
1. Establish Serialization Practices
Serialization is the process of assigning unique numbers to each product pack. Through serialization, manufacturers can identify every unit that leaves their facility, no matter where the product ends up along the supply chain. With this level of traceability, companies are capable of:
- Improving inventory management.
- Efficiently recalling products with a high degree of accuracy.
- Complying with federal regulations such as the Drug Supply Chain Security Act (DSCSA), Physician Labeling Rule (PLR), and Over-the-Counter (OTC) Drug Review, which require complete product traceability.
To successfully complete serialization, pharmaceutical manufacturers must mark each of their saleable units with a series of unique codes. According to federal regulations, these codes must include:
- An expiration date, to inform retailers when to pull the product from the shelf as well as to inform consumers when the product stops being safe for human consumption.
- A serial number, to track individual products throughout the supply chain.
- A batch number, to record what specific combinations of ingredients were used to develop the product.
If one of these codes isn’t included on the product packaging, the manufacturer is likely to face recalls, fines, and negative publicity. Accordingly, it’s essential to establish product coding workflows that ensure each unit is outfitted with accurate, highly legible text and machine-readable barcodes. Thankfully, modern marking equipment like continuous inkjet (CIJ), thermal inkjet (TIJ), and case coding printers make serialization—and other coding applications—simpler to complete than ever before.
2. Use Reliable Marking Equipment for All Coding Applications
When it comes to pharmaceutical product marking, manufacturers can’t afford to use subpar equipment. After all, serialization is only successful if the applied markings can remain legible throughout the supply chain. To avoid logistical problems and fines from both distribution partners and government agencies, it pays to use top-notch coding equipment.
Not only do well-built printers enable companies to mark their products with long-lasting codes, but they also help maximize line efficiency by printing at high speeds and resisting traditionally challenging workplace conditions. For example, CIJ printers, like the DuraCode Touchscreen, and TIJ printers, like the Anser X1, provide maximum printing speeds of around 300 meters per minute, meeting the pace of many industrial production lines.
Further, both of these models are built with sturdy enclosures that provide protection from environmental factors like:
- Dust and other airborne particles
- Extreme temperatures
With the aid of these technologies, pharmaceutical manufacturers can maintain peak productivity as well as comply with rigid traceability standards.
3. Be Ready to Track, Trace, and Verify Each Product
Establishing marking workflows and utilizing reliable printing equipment allow companies to lay the groundwork for full traceability. Of course, tracing actual products requires more tools than that. Specifically, manufacturers must keep accurate lot records and be able to easily access the data in order to verify each product unit. Modern technology simplifies the process.
Inventory software enables companies to easily generate lot codes and track products as they move along the supply chain. A high-quality inventory platform will benefit pharmaceutical companies by providing:
- Complete code records
- Lot tracking, both internally and externally
- Alerts regarding perishable inventory
- Sourcing for all raw materials and ingredients used to produce the product
These tools make it possible for manufacturers to locate all of their products, perform recalls, and verify whether suspect products are counterfeit or legitimate.
Need Help Creating Traceability in the Pharmaceutical Industry? InkJet, Inc. Is Here to Support You
If a company wants to succeed in the pharmaceutical industry, traceability needs to be taken seriously. Without properly applied codes and meticulous inventory records, pharmaceutical manufacturers are liable to face profit-draining penalties and negative publicity. At InkJet, Inc. we know how serious this is.
For over thirty years, we have helped companies in all industries improve traceability by offering powerful marking equipment and durable, cost-effective ink formulas. Call us today to learn how our services can benefit you.
To learn more about traceability in the pharmaceutical industry, contact InkJet, Inc. online or by phone at 1(800) 280-3245.