The work involved in managing product labeling is astronomical – in fact I’d go as far as to say it’s analogous to the manufacturing process. From control of the process, to coordinating all the moving parts, to cross-checking content, to managing reworks and translations, to ensuring traceability and audit trails – it’s time-, labor- and cost-intensive.
Robert Vollkommer, Principal, Regulatory Solutions, CSC
During the Pharma and Device Packaging and Labeling conference held in San Mateo, California, in November 2016, some important themes about the challenges facing labeling emerged. At this time of year, when so many of us are considering our New Year’s resolutions, streamlining your labeling processes should be top of mind. Here are the top 10 reasons why producing and managing the label is as hard, if not harder, than manufacturing a product, and what you can do in 2017 to become a labeling leader.
- It’s a numbers game. There are multiple functions involved in labeling, including clinical, manufacturing, legal, translation; so you have to find a way to bind the information from all those different stakeholders.
- Who is in charge? So you’ve got the data, but who is the responsible party for pulling all that information together? Sometimes it’s regulatory, sometimes it’s a special labeling group. Just as with manufacturing, you need a clear line of oversight.
- Keeping Track. How do you ensure alignment of labelling content from Company Core Data Sheet (CCDS) right through to final artwork creation? And then how do you keep track and report on any variances without having a process that is transparent, inclusive and auditable?
- It’s not just the who but the how. You also have to decide what tools and processes need to be in play to get a handle on all those moving parts and improve efficiency. Just as you need clear oversight of your production line in manufacturing, you must have good tools and clear processes in labeling. Without them, companies struggle with efficiency and accuracy.
- How much is your label worth to you? It’s inconceivable that a company would allow their product to be developed, or for the control process to be managed, on substandard equipment. Building and managing a label with manual processes and minimal technology is a recipe for problems.
- Are you saying it right? Not having clear processes across labeling could put your translation at risk. For example, the word “should” translates to “must” in German, so nuances such as these need to be understood. In the manufacturing world, nuances such as right excipient are recognized as crucial.
- Can you guarantee the quality? You need to be able to measure, analyze and improve on processes so regulators, healthcare professionals and patients have confidence in the information provided on the label. In manufacturing, on the other hand, GMP (good manufacturing practice) is now paramount across the industry.
- Do you have version control? A typical problem is that labeling involves so many iterations and functions that it can be difficult to ensure the right version is being worked on. As a result, companies are spending time and money on solutions to check and compare versions, often late in the process.
- Can you adapt to change? If a phrase needs to be changed on the label. For example, your company has acquired another company and your legal department doesn’t like the phrase on a label. Going through documents manually is a massive, almost impossible task. It would be a bit like going through your old record collection and searching for every song with the word “love” in it, without the benefit of digital search tools.
- Getting your timing right. Labeling is one of the last aspects involved before a drug is released, and labeling or regulatory doesn’t want to be responsible for a shipment or batch being delayed.
With so much complexity involved and so much at stake, regulatory and labeling teams are searching for tools and capabilities that will minimize manual – and consequently error-prone – processes, that ensure version control and that can quickly and accurately make changes without laborious searches through documents.
To overcome the challenges described, you need a solution that allows you to store your label, artwork, translation, description and so on as structured data. You also need to have an audit trail of who has approved it, full version control, notes about any changes that are required, and prompts sent to whoever should be responsible for those changes. Finally, you’ll need a simple way of tracking when the label has been sent to the regulators or a third party, and when approvals have been granted. Such a solution eliminates the constant flow of emails, which are hard to keep track of and impossible to have version control over, and instead ensures everything is contained within the same system.
In a modern, digital age, this is the most logical approach. And it’s what people have come to expect. That’s not to say tools can replace processes or that all manual activity is done away with, but rather that a complete tool together with well-considered processes and labeling expertise will help ensure your labeling does what it’s supposed to – protect patients and meet compliance requirements – without being hampered by burdensome, wasteful and error-prone activities.
Learn more about labeling tools and capabilities and what approach makes most sense for your company by listening to the CSC and Kallik recorded webinar, Leading the Way in Labeling and Artwork Management.