The U.S. Food and Drug Administration’s regulatory requirements for drug labeling aren’t exactly intuitive. Even after consulting the labeling resources provided by the FDA, you may be left with some questions about how to stay compliant — especially since those requirements are constantly being updated.
They might seem overwhelming, but these guidelines are in place for good reason. Unclear pharmaceutical labels and packaging can pose a serious danger to the people relying on medications to stay healthy.
That’s why it’s critical that pharmaceutical manufacturers choose a label printing partner who understands the industry, follows best practices, and can help you stay compliant with FDA regulations. When you work with someone like that, you’ll enjoy four big advantages.
If the label on a bottle of salad dressing falls off, it’s a problem.
If the label on a medicine bottle falls off, that’s life-or-death. That can’t be allowed to happen.
Moreover, pharmaceutical labels are never one-size-fits-all. Application conditions can vary widely from temperature extremes to harsh chemical exposures. Even the specialized sterilization processes routinely used in pharmaceutical production can compromise a label not designed to withstand that type of processing.
Size, too, can be an issue. Smaller drug vials can present uncommonly tight circumferences. Without the right combination of pliability and adhesive, labels on such surfaces tend to become loose at the edges, “flag,” and may even fall off completely.
An expert label printer will consider the pros and cons of different label materials and adhesives, make recommendations, and back up their recommendations with reliable testing data. They’ll know which suppliers to turn to for materials and adhesives that have been specifically engineered and tested to perform according to the demands and challenges of the pharmaceutical industry.
Labeling errors are one of the leading causes behind product recalls in the pharmaceutical industry.
A line clearance involves a complete reset of the production line between print jobs, including removal of all raw materials, inks, and plates away from the press. The purpose of this procedure is to ensure that there can be no potential for mixing label codes within the same batch. By taking care to prevent these kinds of mistakes, your label printer can help you not only stay compliant, but also protect your customers.
It’s an unfortunate truth that criminals are constantly innovating new ways to take advantage of people for the sake of making bank.
In the world of pharmaceuticals, counterfeiting is a serious problem that can harm patients and damage the reputation of drug makers.
But just as counterfeiters have become more sophisticated, so have pharmaceutical companies. One way in which they fight back is via the application of security labels to pharmaceutical products. Sometimes these features are even integrated into the labels themselves as an extra step to thwart counterfeiters. The features of security labels include elements that make them hard to replicate.
Many of those features also facilitate tracking products through commerce or tracing them back to their origins. For example, barcodes and other unique identifiers can be applied to pharmaceuticals, including in some cases to each individual pill. Security elements like these enable improved awareness of distribution patterns and can become invaluable in rare situations where products are found where they aren’t expected.
Given all this, it’s important your label printer understands the latest in security label technology and design. A good partner isn’t just a master of their craft — they’ll also be proactive enough to actively seek out and learn about these kinds of innovations.
Your label may serve as the face of your brand. Maybe it contains important instructions or a life-saving warning. Maybe it’s even all the above.
No matter the purpose it serves or what industry you’re in, it’s critical that your labels are always printed correctly. To that end, any label printing partner you work with should keep a full-time quality control team on staff.
Beyond performing inspections and quality checks, this team should also keep careful documentation of processes and protocols. This helps ensure that every member of staff follows a consistent, repeatable procedure that reduces the chance for mistakes.
This team is also responsible for noting any changes to the labels or printing process and then updating documentation accordingly. The goal is to ensure that the right checks are always in place throughout the production, packing, and shipping processes that have an effect your labels.
To ensure your label printer maintains the highest quality standards, look for ISO 9001 registration.
At The Label Printers, we have supported our partners in the pharmaceutical industry for decades. Our quality procedures were established early on with the guidance of some of our largest pharmaceutical customers. Thanks to those close relationships, we became one of the first label printers in Illinois to qualify for ISO 9001 registration.
To talk about how we can help fulfill the special requirements of your pharmaceutical or medical product label, contact us today.
Want to know more about what goes into a great label? Download our free Custom Label Buying Guide.