How Life Sciences Companies Can Manage Compliance in Packaging

As more regulations come forward with greater complexity, it is important that life sciences companies must adapt quickly.

FREMONT, CA: Packaging and shipping life sciences products has become like navigating an obstacle course. There are national and international regulations to abide by, the recipient’s demands, the common-sense factor, and ensuring medications’ safety from adverse conditions and theft. Because life sciences firms sell products that aim to support their consumers to stay healthy, the packaging needs to be correct and in line with strict regulations. Here is more about how upgrading packaging and artwork management can save time, money and help life sciences organizations avoid breaking regulations.

The key is to develop a system of optimized, defined workflows within packaging processes. This will enable firms to respond to the evolving complexity of label and artwork regulations for packaging quickly. One recent regulation that has transformed the life science industry is the medical device regulation (MDR) for medical devices. The population is growing older, and new technologies are coming to the sector. Countries needed to update their medical device regulations. 

Compared to the Medical Devices Directive (MDD), MDR focuses less on the pre-approval stage of medical device manufacturing and more on a lifecycle approach to medical device regulation. MDD would tell firms how to market, MDR encourages procedures for improving every product life cycle area.

Manual operations and verbal communication, and emails that will inevitably get lost do not comprise any formal reporting structure for regulatory needs. As a result, they can lead to costly errors. However, by going digital with operations, packaging teams can review and annotate any given artwork or label file. This enables information to be gathered into a database—otherwise known as an audit trail. With a digital process, there is accountability and transparency for when and where mistakes occurred.

Firms that have deployed concrete steps to inspect their packaging and prove accuracy and compliance are best matches for continual industry regulations. Comparing, verifying, and inspecting artwork is a crucial part of enhancing quality. Proofing tools can simplify the process through automatic quality checks at each stage.