Pharmaceutical product labelling is a highly regulated process. It plays a significant role in driving product approvals and maintaining data quality and safety. Each labelling leaflet includes important product information like the brand/drug name, manufacturer name, batch/lot number, product description details, usage indications, expiration date and more.
The pharmaceutical labels are an important way to make customers aware of specific formulations of a product and protect them from unreliable usage of the medication.
A product which is available in any geographical market requires compliance with the country/region-specific regulatory requirements. It is said that 50% of pharmaceutical recalls are due to product labelling or packaging artwork errors. Therefore, to avoid recalls and ensure product success, companies must have pharma artwork management solutions at every step of the production.
5 ways to improve labelling and artwork management in life sciences
1. Make labelling a priority
The labelling process is critical for maintaining compliance. Not only does the label act as a unique identifier to prove authenticity to health care professionals, but it also ensures that active ingredients and concentrations are clearly understood. And there cannot be any margin for errors as the consequences of inaccurate ingredients are too high.
A recent survey conducted by NiceLabel Survey revealed that 78% of pharma and biopharma companies don’t have a modern, digital labelling solution in place, and 83% are looking for a new system that can reduce manual tasks and increase accuracy.
Therefore, it is important to ensure that labelling technology is a priority so that it can address inconsistencies in processes, mitigate human errors, enhance label quality, and improve business agility so that companies can produce compliant, high-quality labels in a cost and time-efficient manner.
2. Rise to the challenges
Many pharma manufacturing companies use various software and planning systems. However, the challenge is to integrate the labelling process within these systems. Traditionally, companies were needed to upload label templates separately into the systems, which lead to multiple label templates and inconsistencies. In a heavily regulated market like the pharma industry, it is essential that there is only one true version of each label for both compliance and efficiency savings.
Modern label management systems enable companies to integrate with the data, digitize the label creation process and also empower businesses to handle change requests. This ensures consistency, saves the business time and achieves new levels of quality control and compliance.
3. Ensure regulatory compliance
Meeting federal or international requirements of labelling often requires a lot of paperwork. The Food and Drug Administration has also shifted from requiring paper evidence that introduces vulnerability to human errors to electronic methods of validation to ensure safety and security.
The best modern label management systems now allow business users to design, review, approve and control label data from a document management system to provide approvals, audit history, and electronic signature capability. This increases traceability and eliminates much of the opportunity for errors, thereby providing a fully auditable trail for compliance procedures.
4. Reduce costs
It goes without saying that fewer errors lead to cost savings. And with a modern system, label changes can be managed centrally within the business, eliminating the need for expensive IT resources and the supplication of efforts. As a modern label management system enables labels to be printed more quickly and accurately, production lines can be up and running more promptly, which leads to increased operational efficiencies.
Meeting local, regional and international labelling requirements consistently and efficiently requires pharmaceutical companies to be agile. It is important to have a centralized document management system that can be scaled globally in order to do this.
5. Centralize operations
The pharma industry, like many others, has to deal with the global-versus-local dilemma when it comes to labelling its products. Centralization means more consistent and accurate labels. However, the vast amount of local and regional regulations and compliance can make this a challenge. And pharma companies may also look to mitigate the risks associated with downtime by spreading their production facilities and labelling centres across several countries.
However, a modern labelling system has the benefit of both worlds because it can adapt to the IT layout of individual companies.
Conclusion
A modern, centralized artwork management system can yield impressive results like improved compliance and consistency, increased efficiencies and agility, improved template consolidation and governance, and a scalable platform for growth.
With a modern artwork solution, companies are in a far better position to address future regulatory changes, like serialization, allowing them to continue bringing drugs to market that improve the lives of millions of people around the world.
