The pharmaceutical industry arguably faces more challenges than most other industries. Regulatory compliance is part and parcel of working in the sector, but, in a business where bringing a drug to market carries such a large investment, cost pressures, particularly when a drug comes off patent, are perhaps higher than for many other businesses.
Therefore, finding the balance between complying to regulation, driving efficiencies in the manufacturing process and maintaining quality can mean the difference between being competitive or not.
A critical part of maintaining compliance and safety standards for any drug manufacturer is the labeling process. Not only does the label act us a unique identifier to prove authenticity to health care professionals and consumers, it also ensures that active ingredients and concentrations are clearly understood. And there can’t be any margin for error as the consequences of inaccurate doses or ingredients are too high.
In fact, it’s estimated that 50% of pharmaceutical recalls are due to errors in product labeling or packaging artwork. Therefore, it makes sense to ensure labeling technology is a priority, so it can address any inconsistencies in processes, mitigate human errors, enhance label quality and improve business agility in order for the company to produce compliant, high-quality labels in a cost and time-efficient manner.
Typical pharma labeling challenges
Traditionally, pharmaceutical companies have purchased label printers locally, on a plant and country level. This has resulted in many fragmented and disparate label software and printing solutions within the same organization.
This fragmented landscape is further complicated by the fact that plants often use separate printing systems for labeling and direct marking tasks. Add to this the need to comply with market and country specific labeling requirements, and the result is a label database containing thousands of label variants.
Creating multiple label templates across multiple systems in various regions is a costly and laborious process, even when that process is digitized. The more manual the procedure, the higher the likelihood for errors.
A fragmented labeling environment also makes it challenging to process label change requests in a timely, efficient manner. This can cause many issues, especially when regulations in some markets, such as FDA CFR 21, require documenting every change in the system, including new and updated label templates.
A modern label management system can address these issues. By centralizing and digitizing labeling, pharmaceutical companies can create an efficient, streamlined process for producing accurate, compliant labels.
Benefits of a modern label management system
A modern label management system digitizes the entire label management process, from label design to printing and management. It includes a centralized, digital label catalogue that controls and streamlines label lifecycle management. It eliminates the need for paper-based catalogues and prevents the creation of data silos. By introducing role-based access, configurable approval workflows, and document versioning and electronic signatures, a modern label management system helps prevent unauthorized label changes and provides the necessary documentation to comply with regulatory requirements. It includes label variant technology that can help pharma companies drastically reduce the number of label templates they have to maintain.
A modern label management system can also be integrated with Manufacturing Execution Software (MES) and Enterprise Resource Planning (ERP) systems. This integration provides a single source of the truth for label data.
It also solves the challenge of a fragmented label printer landscape by introducing universal templates that work across all label and direct marking printers. This means pharma companies get one, centralized labeling system that can guarantee correct labels regardless of the printer make, brand or location.
How pharma companies benefit from modern label management
An example of how pharma companies can benefit from implementing a modern label management system can be seen in the case of Boehringer Ingelheim. It has been able to implement a global, standardized labeling process with digital quality control and ERP integration. This has enabled Boehringer Ingelheim to eliminate its manual quality control procedures and institute a centralized way of updating label information, therefore processing change requests more quickly than before.
A solution for now and the future
Going forward agility, accuracy and compliance will be key to pharmaceutical companies competing successfully in a very challenging marketplace. A modern label management system is a vital component in achieving this; however, the benefits don’t end there. By putting the right system in place now, and removing inefficiencies from their labeling process, pharma companies will have a solid foundation for manufacturing process improvement. And they will also be in a far better position to address future regulatory changes, such as serialization. With the right framework in place, pharma companies will be well positioned to meet current, and future, challenges.