Pharmaceutical Trade Tips for the Printing Industry
by Ryan Szporer
Printing leaders aren’t just at the top of their industry. In many ways, they also need to be experts of the domains in which they do business. Printers take different approaches to cater to specific clients, like in the pharmaceutical industry, for example.
Standard Operating Procedures for Pharma
When it comes to packaging, the pharmaceutical industry is a tad distinct. Even relative to the food industry, in which consumer safety is paramount, pharma has it much more severe in terms of printing standards.
As a result, whereas in the food and beverage sector, branding is everything and there is the emphasis on colors and visuals, it’s different in pharma. Instead, drug companies focus more on the accuracy of documents than color when performing quality control.
As Standard-Operating-Procedure (SOP) compliance for pharma companies is necessary, there is instead emphasis placed on elements “designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100).” And understandably so. The ramifications for a simple misplaced or missing character in the dosage info on a carton can be lethal.
That isn’t to say branding is unimportant. However, in the context of the sector, it’s more so anti-counterfeiting, brand-protection features that are front and center. These features include specialized ink, Radio-Frequency Identification (RFID) tags, and serialized, invisible marks on the packaging of each unit.
Greater Hardware and Software Flexibility
Product serialization, which enables the identification and tracking of each package throughout the supply chain, is actually required by the Food and Drug Administration. The FDA seeks to enforce it through the U.S. Drug Supply Chain Security Act (DSCSA).Companies now have until November 2018 to meet specific requirements, with several unique serialization challenges presenting themselves. For example, first incorporating the label re-design into the packaging workflow and maintaining the same level of production efficiency as a result.
The trend towards greater serialization in the U.S. underscores arguably a greater need for flexibility among printers. After all, the U.S. represents a single segment of the global population. Different countries have alternative standards and regulations that must be taken into consideration during print runs, which are becoming shorter and shorter. That’s thanks to an increase in demand for personalized medications as well.
The need for greater flexibility is being addressed by a transition to specialized equipment and software to both manage serialization and verify printed and packaging components. That includes vision systems and automated/ digital proofreading solutions, which can be easily configured to accommodate different jobs and minimize downtime for printers. Specific solutions can also check and grade the barcode or data matrix containing all the required serialization information so as to prevent issues at the point of sale and additional recalls.
Seeing the Transition in Pharma Through
As runs become smaller, the packaging process moves closer to that point of sale to maximize efficiency especially with regard to distribution. Combined with potentially over-bearing financial costs associated with having to replace equipment in the wake of the advent of the DSCSA, drug manufacturers are teaming with contract packagers to reduce their role in the process. This can theoretically mean more work for printers (or at least firms with contract packaging and printing services), as long as their processes have been sufficiently overhauled to meet the strict requirements of the industry… not to mention those of the individual customers themselves.
The transition to greater transparency within the industry is seen as being out of necessity, which is true for a variety of reasons. The road is set to be long, in spite of the ironically shorter runs it has borne. It can at least be facilitated by minimizing errors in the supply chain or catching them early in the process.
As the packaging process shifts closer to the point of sale, new challenges have emerged, but printers can more than compensate by keeping pace with technological advancements in quality control. Errors can be traced back to the exact touch point at which they were introduced, ultimately leading to greater accountability and, in turn, fewer mistakes.
Track vs. Traceability
Traceability for the purposes of nipping counterfeiting efforts in the bud is probably the main goal, but the fewer recalls that will result is a worthwhile by-product, here. That’s especially true as it translates to a higher level of satisfaction on the part of the customers, who are at least theoretically the primary concern in an industry such as pharma.
Whereas the aforementioned RFID tags help on the back end, Near-Field Communication (NFC) labels are a sub-category that is more customer-facing. Patients can access information on the pharmaceutical product they are looking to purchase directly on their phone (assuming it’s NFC-enabled). NFC functionalities that are in the works include the abilities to confirm packaging hasn’t been tampered with, check dosage information, get reminders to take pills, and earn loyalty-program rewards.
The goal is to make labels “smart,” which is one way to interpret the desire to create a better customer experience. It clearly starts at the file-creation and artwork-design phase.