Pharma labeling, Bringing a new drug to market takes significant investment. By the time it reaches manufacturing status, hundreds of millions of dollars will have been spent in the trial and development phases.

Once the drug enters the manufacturing process, meeting regulations and maintaining compliance adds more costs to bringing it to market. Therefore, any procedure or technology which can improve product quality and efficiencies within the manufacturing process and allow for a quicker return on investment is highly attractive.

The labeling process is a critical part of pharmaceutical manufacturing, and if modern labeling systems are deployed, efficiency savings can be made without compromising on standards or regulations. 

Making labeling a priority

The Pharma labeling process is critical to 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 can’t be any margin for error as the consequences of inaccurate ingredients are too high.

A NiceLabel survey revealed that 78 percent of percent of pharma and biopharma companies don’t have a modern, digital labeling solution in place and 83 percent are looking for a new system that can reduce manual tasks and increase accuracy.

It makes sense to ensure Pharma labeling technology is a priority so it can address inconsistencies in processes, mitigate human errors, enhance label quality and improve business agility in order for companies to produce compliant, high-quality labels in a cost- and time-efficient manner.

And for multinational pharmaceutical companies, the task of labeling has become even more difficult and time-consuming. Besides Good Manufacturing Practice (GMP) that aims to minimize any risks associated with incorrect labeling, there are local regulations which need to be adhered to, and the consequence is that companies need to manage multiple label templates for many countries, leading to a higher chance of mislabeled — and therefore recalled — products. In addition, new labeling technologies such as 2D bar codes and radio frequency identification (RFID) tags need to be managed into the overall labeling process. 

Essentially, in today’s climate, all pharma companies are looking to ensure compliance, minimize the need for relabeling, reduce the number of label templates, and to transition from paper-based catalogs to digital document management systems.

But there are several challenges that must be overcome first before these benefits can be realized.

Rising to the challenges

Most pharma manufacturing companies use Manufacturing Execution Software (MES) and an Enterprise Resource Planning System (ERP). However, the challenge is in integrating the labeling process within these systems. Traditionally, companies have needed to upload label templates separately into the MES and the ERP system, leading 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 labels with the master data, digitize the entire label creation process and empower business users to handle change requests. This ensures consistency, saves the business time, and achieves new levels of quality control and compliance.

The whole compliance process can be streamlined with an electronic label lifecycle management system. This saves countless man-hours, improves customer response times, and leads to consistent label output across all systems. 

Ensuring regulatory compliance

With a legacy approach to labeling, meeting federal or international requirements often requires a lot of paperwork. The U.S. Food and Drug Administration has moved from requiring paper evidence — which introduces vulnerability to human error — to electronic methods of validation using computer technology to ensure safety and security. In addition, regulations such as FDA 21 CFR Part 11 and Eudralex EU GMP Annex 11 guidelines require companies to demonstrate compliance in regard to accuracy and security of their electronic records.

The best modern label management systems now allow business users to design, review, approve and control label data from a document management system, providing approvals, audit history (who, what, when and why), maintenance of records and electronic signature capability. This increases traceability and eliminates much of the opportunity for errors, thereby providing a fully auditable trail for compliance procedures. 

Maintaining safety standards

Errors due to inaccurate labeling can cost money and lives. In addition, drug shortages, which are frequently caused by quality and safety concerns, can also impact patients’ lives. And with so many drug recalls attributed to errors in product labeling and packaging artwork, it’s not acceptable to rely on legacy and inaccurate systems.

A modern label management system manages the entire label lifecycle, offers complete transparency throughout the label production process and facilitates quality control procedures.

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