Are you compliant? That’s a question that keeps regulatory affairs executives up at night, particularly in light of increased responsibilities and prosecutions. Where this question becomes even more difficult to answer is with Labelling, since this is an area that traverses so many parts of the enterprise.
Among the factors regulatory affairs must contend with are that very few organizations have complete oversight and most struggle with highly disconnected processes. For example, during the approval process for any Labelling asset, information will likely be sent around the organization in emails or in email attachments. This might consist of a phrase on a label or package, a piece of artwork or a translation required to meet local market regulations. And it’s not easy to trace that information and demonstrate where it originated when it’s managed in such a haphazard way.
Another issue with maintaining oversight is that the vast majority of Labelling activity is driven by required changes. In fact, companies we speak with say changes account for between 75 and 90 percent of their Labelling activities, and most of these changes are regulatory related — because of new legislation or localized symbols or label changes to gain approval for entering a new market. So while the product itself has few or no changes, the Labelling content is constantly being updated and changed.
With so many changes to manage and information coming from multiple stakeholders, it’s difficult to know whether you’re working on the latest approved version, or even if everyone is working from the same version. Changes made locally are often not reflected back upstream, increasing the chances of having multiple uncontrolled versions of the same artwork. It’s a classic problem — how do you know whether you have the latest version? What is the version control process? And who has signed off on the document?
Compounding this lack of visibility is the demand for greater traceability in light of a heightened focus on patient safety, as well as growing concerns over counterfeiting. If problems arise with products leading to product recalls, such as the breast implant crisis in France a few years ago, being able to trace a product through accurate Labelling is crucial.
If it turns out that you are working on the wrong version and the label that gets onto the market doesn’t have the latest regulatory information or you don’t have proper oversight of that label, you face serious ramifications. For example, your product might be at risk of recall, delayed entry into new markets because of noncompliance with local legislation, wasted time and resources from having to scrap incorrect labels, brand damage, fines, and of course loss of time and loss of revenue.
While you may very well be compliant and your label may meet the various regulatory requirements, the real issue is lack of insight into your Labelling processes. In other words, “you don’t know what you don’t know.”
In my next blog, I’ll explore how you can address these challenges to ensure consistency, oversight and transparency.
Learn more about Labelling by downloading our white paper, “Connecting the Dots Across the Labelling Life Cycle.”