Current Challenges for the Labeling Process in the Pharmaceutical Industry
Are you comfortable with your current end-to-end (E2E) labeling processes? Or have they become unwieldy? With a massive amount of content and increasingly more complex regulations, you need a fully integrated solution to manage it all.
Complexity of Systems
Pharma companies use multiple systems to manage labeling and artwork. These solutions are complex and often disconnected. Things get really dicey when they don’t play well together.
Lack of Visibility
Are there things happening in your processes you don’t know about? And if you don’t, who does? Face it, without visibility, you’re working in the dark.
Manual / Email Handoffs
You wouldn’t make important changes to content and artwork on the back of a napkin. But is it any better to attempt to do so by email or manual hand-offs? Both are risky and error prone.
A streamlined end-to-end labeling process for the pharmaceutical industry
Scroll over each stop to follow the process
CCDS Update Request
- A formal change request is submitted to kick-off the labeling change process.
CCDS Authoring
- A content author will update the Company Core Data Sheet (CCDS) as a first step to capturing the required change.
CCDS Approval
- The CCDS approval process occurs prior to any changes to the labeling content that will be submitted to a HA.
Content Creation / Prep for Submission
- All content required for the HA submission will be created and approved. How this is executed across countries and regions may vary based on types of products (centralized, decentralized, national, mutually recognized) and lead country/reference country relationships.
Regional Update
- Different regions may have different HA requirements they must follow.
Localization
- Translations will be needed in many markets – in some cases multiple translations, along with other local changes needed to accommodate a local population.
HA Submission Ready
- Depending on a company’s roll-out strategy, HA submissions may be done in phases or in parallel.
HA Approval
- The HA submission & review process is a collaborative effort that may take weeks or years, depending on the change. Once this process is complete, the release of new labeling can occur.
Output to RIM
- The end-to-end labeling process encompasses an eco-system of technologies. An example of this is a Regulatory Information Management (RIM) system. Integration points may exist throughout the process for the exchange of data, content, or project status to create a streamlined process, removing the need for duplicate data entry and providing end-to-end visibility.
Labelling Change Notification
- Many events can trigger a labeling change, such as a safety, indication, storage, shelf-life, and even a corporate branding change. This notification will capture the type of change, along with details for the labeling team to begin the change process.
Impact Assessment
- Decisions will be made regarding what labeling needs to change, when it’s needed by, and which countries are impacted. A bundling/ unbundling assessment will also be completed (i.e., any impacted labeling currently in a change process and how should this new change impacts that activity).
Change Request
- A formal change request is submitted to kick-off the artwork process.
Artwork Mockup
- In many countries an artwork mockup is required with the Health Authority (HA) submission package. These mockups will include updates to content and layout as needed for the change and are mostly final.
Labeling Content Ready
- Once HA approval has been received, time is of the essence to hand off to supply chain for execution. The product packaging can be finalized for the print process.
Final Artwork Creation
- Artwork is being finalized, including any technical requirements for the print process. All regional versions are also being finalized at this stage or staggered based on required implementation dates.
Artwork Approval
- Any change to artwork requires an approval process. An initial approval may happen earlier in the process for content changes, but at this stage, a final approval may be needed before the print process begins.
Ready for Print
- All content and technical aspects of the artwork have been approved and it’s ready for the print process. Available inventory may factor into the timing of the print process.
Global Regulatory/Labeling
- Compliance isn’t a nice-to-have. When it comes to using a system to manage labeling and artwork, it’s a requirement. The impact of being caught short can be enormous to patient safety and your business.
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Global Artwork
- When it comes to Pharma, artwork is a lot more than a pretty picture. Pharma artwork is a serious business where the consequences for mistakes can be deadly. Artwork must not only be current and accurate, it must be easily shared and traceable.
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