Labeling, one of the most critical processes in the lifecycle of a pharmaceutical product, can be defined as all the printed information included with over-the-counter medicines or prescription drugs. Over the years, pharmaceutical labeling has become quite challenging. Both the creation of labels, and the implementation are complicated by continuously changing regulatory requirements. This requires collaboration across several teams.
This article introduces three labeling teams that are required to conceive a good and clear label.
- The first labeling team is strategic and focuses on the content of the label.
To be a labeling strategist, good knowledge of regulatory requirements and a strong scientific background are required in order to be able to communicate with medical and safety scientists.
- The first team should be able to connect with a second team that is responsible for labeling execution and implementation.
Once the content is finalized, they must find a way to present it in an optimized and functional manner to ensure that the label is accurate and compliant, and is handed over to supply chain in time.
- In larger organizations, a third team is responsible for the coordination and compliancy tracking.
This requires good end-to-end labeling process insight and knowledge of quality and regulatory requirements.
Good data processing and information technology skills are of use.
Tracking systems and metrics, end-to-end tracking of label statuses and timelines result in compliance oversight and - more importantly - in the safe and effective use of drugs.
READ FULL ARTICLE (Source: RAPS).