Recalls of pharmaceutical products spiked 52 percent in Q1 2018, the highest since 20131. Though the average recall size has been declining in recent years, due in part to serialization and SKU proliferation, pharmaceutical companies continue to look for automated equipment solutions that can help prevent recalls. Sixty-two percent of pharmaceutical companies predict spending more on capital in the coming months, according to the 2017 Evolution of Automation Report, by PMMI, The Association for Packaging and Processing Technologies.
From labeling to quality control, there are areas for improvement that can reduce costly, time-consuming recalls. Innovations in automation technology can help companies identify vulnerabilities and limit instances of human error before they happen, preventing damage to brand integrity, consumer perception, and the bottom line. The PMMI-produced Healthcare Packaging EXPO, co-located with PACK EXPO International, (Oct. 14-17, 2018; McCormick Place, Chicago) will showcase many of these recall prevention solutions. Before specifying key technologies, pharmaceutical manufacturers should consider a few ways to strengthen their operations.
Preventing Packaging and Labeling Errors
An estimated 50 percent of pharmaceutical recalls are related to labeling or packaging artwork. Small but problematic details can lead to significant inaccuracies in pharmaceutical packaging and labeling. Common mistakes include gross errors, which occur when necessary information is missing from artwork, context and meaning flaws, content mistakes, and technical errors such as dysfunctional barcodes. Once a problem occurs, it is necessary to identify the source to avoid recurrence.
To avoid recalls caused by labeling errors, companies must inspect the artwork at every step of production, ensuring the accuracy of text, labels, design, braille content, and barcodes. Innovations in automation now allow pharmaceutical companies to implement all-in-one quality control platforms that check text, spelling, artwork, graphics, braille, and barcodes at every stage of production.
Packaging quality control platforms should follow the rules and regulations of pharmaceutical quality control standards. Pharmaceutical companies should look for systems that are able to read and inspect labels and compare different label formats.
However, many companies still rely heavily on human labor for labeling processes, which can invite opportunities for mistakes. More than 60 percent of all recalls stem from human error2. Some common reasons for mislabeling include inconsistencies in process, gaps in competence, rushed manufacturing, and mistakes in reference information. Outdated systems also can be problematic. When stored in too many different places, assets get lost in the shuffle and companies run the risk of working from outdated or incorrect documents.
Automation can go a long way in limiting instances of human error, but it is critical to make the switch with care or companies can invite more errors. Integration into the existing workflow so only minor changes are made can help team members adapt to change and succeed in avoiding packaging recalls caused by errors from using a new system.
Boosting Quality Control in Packaging
Quality control issues throughout the packaging process are another potential source of recalls. Working within one of the most highly regulated industries, pharmaceutical manufacturers must prioritize Good Manufacturing Practice (GMP) compliance. Pharmaceutical manufacturers must consider the quality of the packaging itself, testing and validating it to ensure it meets required anti-counterfeiting measures and child-resistance features.
Sometimes contaminants in packaging, like microscopic pieces of glass, can make the end product dangerous, leading to recalls. To avoid such errors, pharmaceutical companies can integrate a machine vision system with optical character recognition (OCR) technology that ensures packages meet regulatory requirements without slowing down production. The OCR technology allows robots to “see” as humans would. Such machines help pharmaceutical manufacturers meet strict regulations and ensure product safety.
For example, Antares Vision offers a range of inspection systems for blisters, cartons, trays, aluminum foils, leaflets, and labels that check for foreign objects and verify packaging and artwork. The system allows pharmaceutical manufacturers to quality check throughout the manufacturing process, from single-product units, like pills and capsules, to finished packaged products like vials, bottles, and tubes.
Working With a WES
Prevention is always the best course of action in minimizing the impact of recalls. Companies should periodically review and update their preventative controls. The next best thing is preparation for swift and effective response. To act quickly, pharmaceutical companies should connect a warehouse execution system (WES) to external systems throughout the supply chain. This can help prevent contaminated products from ever leaving the facility.
A WES is warehouse software that combines a warehouse management system (WMS) and a warehouse control system (WCS) into a single application. The WES helps manufacturers and distributors direct, control, and optimize internal material flow and order picking.
An integrated WES system can help manufacturers discover and act upon recalls sooner. By detecting recalls early, manufacturers can better understand what specific product needs to be recalled and focus only on the affected inventory. For example, Honeywell (Booth S-2560) offers its Momentum line of WES technologies to address the increasing complexities in manufacturing. It combines multiple software systems into a common code base.
WES solutions can also provide automatic alerts when products are contaminated, so pharmaceutical manufacturers can prevent bad product from ever leaving the facility. WES can automate the recall process, guiding individuals through to ensure complete, well-organized, thoroughly documented, and efficient product handling. WES systems allow for track-and-trace from origin to point of sale and easily allow companies to provide their customers with all of the information they need to identify and return recalled products efficiently, saving time and money.
In 2017, the U.S. Department of Agriculture (USDA) integrated recall information into its FoodKeeper app. Across industries, apps have emerged to alert consumers to recalls, and some retailers even incorporate recall information into their apps, promoting the feature as a public service. Since 60 percent of consumers look up product information and prices while using their mobile phones in stores, this trend will likely continue in the pharmaceutical industry3.
Finding the Right Solution
The effects of drug recalls are severe, making it very important to prevent them before they happen and prepare a course of action for speeding up and streamlining product removal when needed. Automated solutions can help pharmaceutical manufacturers do just that by reducing instances of human error in labeling and quality control.
Automation can also be a powerful connector, streamlining communication through the supply chain to ensure a problematic product never reaches consumers—and if it does—ensure that all parties are quickly informed and understand the next course of action. Attendees at Healthcare Packaging EXPO will be able to explore state-of-the-art healthcare packaging and labeling technologies in person, including advanced labeling solutions, inspection systems, and WES solutions. To register, visit www.hcpechicago.com.
About the Author
Sean Riley is the senior director of media and industry communications at PMMI. PMMI, The Association for Packaging and Processing Technologies, represents more than 800 North American manufacturers and suppliers of equipment, components, and materials as well as providers of related equipment and services to the packaging and processing industry.