How to Avoid Complete Medicine Recalls due to Labeling Errors



The pharma industry, is by far, the most demanding industry when it comes to quality control of packaging. The processes, rules, and regulations are complex and must be adhered to.

Unfortunately, because many companies still implement manual packaging and label artwork inspection, these results are often prone to human error, which is the most common cause of complete recalls due to labelling errors.

Although recent changes in packaging and labelling are pointing in the direction of process automation, a huge percentage of big companies are not there yet. This is due to the fact that human resources have a hard time adapting to a workflow change if the new process hasn’t been defined clearly.

Define the change process and new packaging quality control workflow clearly

Switching from manual to automated may sound easy, but if the department team members don’t have the required technical knowledge the process can be slowed down radically. What was supposed to be the solution to avoiding labeling errors, becomes the cause of it.

This is why it’s crucial to train all of the department staff in the use of process automation tools. Additionally, integration into the existing workflow so only minor changes are made and process automation SOP’s are the best methods to help  team members maximise the benefits of the change, succeed in avoiding packaging label recalls because of errors, and speed up the process from months to days.

Reports at each stage of label production

Generating reports at each stage of the label production and quality control processes and approvals, helps compare current and prior job versions. These reports should show the changes made during the exchange; who made them, and the label errors which may have occurred between a master and a sample design and text.

Reports are also crucial at the point in which the master job has been sent to the printer or the printing supplier. They enable final verification to ensure that error-free labels are being sent to the printer.

Inspecting the artwork at every step of the label production

As already mentioned, rules and regulations covering packaging quality control in the pharma industry are very strict. This is obviously because patient safety is at stake, along with the brand compliance to fulfill the demands of the regulations.

Companies often use different tools for packaging artwork production and quality control. All parts of the artwork must be inspected. These include  parts such as; text, labels, design, braille content (required on pharmaceutical packaging), and barcodes.

Often, many companies inspect some or most of the parts manually. This practice has shown itself as ineffective, inefficient and risky. It may take hours to verify some of the parts of the packaging labels and the job often goes through many team members. This kind of inspection set-up opens the door to the occurrence of labeling errors.

Automation technology advancement

Packaging quality control automation technologies have evolved over the recent years. Today it is possible to integrate an all in one quality control platform into your production process and workflow so that at each stage of the production, inspection is implemented via software tools and printing inspection hardware. This includes inspection of text, spelling, artwork graphics, braille text, barcode, pre-print and print.

A good packaging quality control software platform should adhere to the rules and regulation of the pharma quality control standards. It should be able to read and inspect various formats and compare different formats to each other.

In other words, a pre-print proof job has to be comparable to a digital format in form of image, text, or graphic.

Finally, an automation platform for packaging quality control should guarantee a maximum return on investment, maximum time efficiency and maximum risk reduction in terms of eliminating labeling errors. 

Contribution written by Marvin Magusara of Global Vision Inc. 

RECOMMENDED