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 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 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.
A modern label management system manages the entire label lifecycle and offers complete transparency throughout the label production process.
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.
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 duplication of efforts.
And 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.
Implementing a standardized label management system has made life easier and reduced costs for Bilthoven Biologicals, a vaccines manufacturing based in the Netherlands. Now that label production is integrated with the MES and ERP systems’ master data, quality assurance tasks are easier to perform, thus reducing the labor costs associated with using a quality person to check each shipment. In addition, instead of struggling to support a wide number of different systems, the IT department only has to focus on one system. This means less unplanned downtime, as the IT department can quickly respond to and address issues.
Having a standardized label management system has extended the cost savings for Bilthoven Biologicals beyond label printing. They have been able to reduce the variations of labels needed, the amount of label stock required, and the number of suppliers used. By moving from keeping a large inventory to a Just-in-Time inventory system, they are able to free up cash reserves and operate in a more agile manner.
Meeting local, regional and international labeling requirements consistently and efficiently requires pharmaceutical companies to be agile. It’s important to have a centralized document management system that can be scaled globally in order to do this.
Managing the supply chain
Deploying a modern label management system is an excellent way to achieve consistency and efficiency in the supply chain. Using the latest generation client-side web printing technology, suppliers can be given access to a company’s centralized label management system, meaning that whatever they supply comes correctly labeled and ready for distribution or integration into another production process. This saves time, eliminates a potential source of error and cost, and ensures consistency across the supply chain.
Using a browser-based interface also enables shop-floor users to access and print centrally managed labels and data, thus improving label and brand consistency while reducing mislabeling across different departments, offices and sites.
Having a web-based system is the best way to manage a multiuser environment, and it also provides the transparency, tracking and access control highly regulated environments require.
The pharma industry, like many others, has to deal with the global-versus-local dilemma when it comes to labeling 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 labeling centers across several countries.
However, a modern labeling system has the benefit of both worlds because it can adapt to the IT layout of individual companies. For example, if a company has a centralized ERP system, then it will most likely choose a centralized label management system. If it has a decentralized MES, then it can use the same system to decentralize label management, while still benefiting from some aspects of centralization.
Positioning for the future
A modern, centralized label management system can yield impressive results such as improved compliance and consistency, increased efficiencies and agility, improved template consolidation and governance, and a scalable platform for growth.
And labeling requirements are more likely to tighten than relax as concerns increase about the counterfeiting, tampering and gray market distribution of pharmaceuticals. The World Health Organization has raised concerns about drugs being marketed with no active ingredients, as well as incorrect amounts of the active ingredient, or containing other toxic chemicals. And often these drugs have been contaminated with microbes due to the unhygienic conditions in which they are often manufactured. The consequences of this are difficult to contemplate but often these drugs are very difficult to detect due to their realistic appearance. This is where labeling can make a difference.
With a modern labeling solution, companies are also in a far better position to address future regulatory changes, such as serialization, allowing them to continue bringing drugs to market that improve the lives of millions of people around the world.