current landscape & challenges
Large-scale, high-volume, artwork content changes come about through two (2) ways; external Regulatory changes introduced by the health authorities and internal business-driven changes.
Keeping pace with the health authority Regulatory changes and codes is challenging from both volume and frequency perspectives. In the last four (4) years, China’s NMPA introduced a new Drug Traceability code, Health Canada 2-D barcode guidelines, Korea’s MFDS electronic patient leaflet and US FDA’s new serialization codes, to name a few. Adding to these challenges are Mergers & Acquisitions, internal reorganization, MAH transfer, manufacturing site change or any new product changes.
Today, due to the COVID-19’s knock-on problems of supply chains and external production being disrupted, there is a real impact on launching new drugs. The industry is experiencing delays simply because they cannot get their product packaging produced in time for launch.
All of which means there are pressing needs to implement artwork changes on time, shorten these production timescales for large product portfolios marketed across multiple countries and stay in compliance.
Freyr has developed an innovative solution for artwork file generation, automatically identifying and incorporating the necessary changes from label content.
The label content changes can be auto-generated in two (2) approaches; first through the auto-generation of artwork annotation for further processing and review; and second by direct auto-generation of the final artwork.
We have designed the solution to auto proofread the formatting as well as the content checkpoints for respective regions in the given document. Finally, the artwork solution will perform a quality test of the output document, generate logs for tracking and review and make the final document ready to download.