How automating your pharma packaging process reduces risk

Oct. 21, 2019
Each manual step in the process introduces the potential for errors, a fear for every pharma and medical device company.

When I started working in the label and packaging industry almost 20 years ago, I was surprised to learn how many manual steps were required to physically change the appearance of a packaging label. And of course, each manual step in the process introduces the potential for errors, a fear for every pharma and medical device company. An error equates to rework — leading to delay-to-market or worse — puts patient safety at risk.

Twenty years later, while there are better tools for data collection and Quality Control (QC) checks, teams are still doing a lot of manual work.

Here’s a look at what happens when an artwork change is needed:

1. A change request is completed

These changes can come from multiple departments
Somebody consolidates all the change request information
The change request needs to be approved

2. An impact assessment is done to determine what artwork needs to change. 

Often times it is difficult to figure out what labels, cartons, Instructions for Use (IFU), etc. are impacted by the change

3. The previous artwork (PDF) is found and marked up with the changes required, and/or a manuscript (Word doc) is used to describe the changes required.

4. The production artist finds the previously approved production (AI) file and checks to see if it is currently in a change process.

5. If the label is already in the midst of a change process, a decision needs to be made about timing and bundling of the changes.

6. Once the right version for change is determined, the production artist can go ahead and make the change by either manually keying the updates in the production file, or doing a copy/paste from the source document (mark up on previous PDF or manuscript) into the production file.

7. A PDF is created once the changes are done and routed for approval.

8. Approval cycle(s)

9. Release of approved file.

 One of the biggest areas of opportunity to reducing manual steps lies in step No. 6: how the changes are applied to a file.

What’s the problem with how changes are applied to the file?

I’m personally a big fan of the copy/paste feature, and I use it all the time. But have you ever copy/pasted something into a document or email, and then realized you had the wrong window open and it got added in the wrong place? Or thought you’d copied one thing only to see that something else got inserted? A production artist must be vigilant in ensuring this never happens when applying changes to a label. 

Another common scenario for label creation is that the same piece of content is used in multiple places on artwork (the back panel and the front panel of a carton). When the production artist goes to copy/paste a label update, he or she may update it in one place but miss another. Taking it one step further: Imagine a scenario where a regulatory change creates a requirement to change a warning statement. The warning statement needs to be applied to 20 products sold in 50 different countries — now that’s a lot of copying/pasting! And the risk of errors jumps dramatically higher.

Yes, companies have built Standard Operating Procedures (SOP) and Quality Control (QC) steps around this process to protect against mistakes, but we’re human, and every once in a while, errors occur.

An automated process

Instead of copy/paste — automate. Tools to automate artwork changes now exist.

Content management is part of the solution to reduce errors, and many companies are now using Product Lifecycle Management (PLM) or similar systems to help with the process. Another part of the solution is linking the content directly to the label so that changes made to the content can be automatically applied to the artwork. No more copy/paste. 

Using automation, content, whether copy or icons or graphics, can be stored in a database and linked to the artwork it’s used on. The content is approved before the change is applied to the artwork, ensuring everyone agrees on the change before the artwork change is completed. In addition to Content Management, the artwork is templatized to identify where each content element is displayed. Then once the content is approved, it can be automatically updated in the artwork. Not only does this remove the copy/paste step, but it reduces the number of more costly cycles in the artwork stage.

Keep in mind here that automation is not a catch-all solution. You should still keep your approvals, and QC checks, but by adding automation into your process you can improve overall packaging quality, streamline the process and reduce risk. 

Many packaging and labeling management technology companies offer different approaches for this capability, but here are some things to keep in mind if you are looking at options:

  • Find a solution that works with industry standard tools (e.g. Adobe Illustrator). If you decide to switch vendors a few years from now, you don’t want all of your files to be in a proprietary format that you can’t use.
  • Find a partner that either offers a content management system or can integrate with PLM or other commonly used content management systems if you already have one. If integrating, a vendor that uses industry standard methods of integration will help simplify this effort.
  • Find a solution that integrates with digital asset management (DAM) tools that allow you to easily access appropriate media assets and files needed for not only your packaging but ad/promotional materials.
  • Find a partner that understands the label change process and understands how artwork is built. Artwork can be complex and templating it to accept automation requires some expertise.
  • Find a solution that integrates the automation right into the change and approval process so that you have full visibility and traceability into the process.

Implementing automation as part of your change process isn’t something that will magically occur overnight. The content will still need to be centrally managed, and the artwork needs to be “templatized” to accept the content directly from the content management system. And SOPs and QC steps need to change to accommodate this new automation capability. It’s a big undertaking, but with a big reward.

About the Author

Jackie Leslie | Account Executive