Best Practice of Labeling in a Challenging Manufacturing Landscape

A number of challenges for the global pharmaceutical industry are perhaps now higher than ever before. Competitive pressures, new stipulations from governments and regulators, products coming off patent and market pricing pressures have combined: pharmaceutical companies are increasingly obliged to seek competitive advantage through efficiency and cost reduction measures. Among the available options, labeling technology offers many opportunities for pharmaceutical companies to successfully tackle rising challenges. A typical wish list for a major pharmaceutical company would be to:

• Align and harmonize label requirements.
• Establish ownership and governance for label content, including creation and maintenance of layouts, outside the company’s IT department.
• Reduce the number of label layouts, particularly redundant layouts due to different systems.
• Transition from paper-based labeling catalogs to digital document management systems.

• Reduce the amount of development required to a minimum.
• Split data and design modeling.
• Enable compliance with increasing regulatory requirements.
• Minimize the need for relabeling.

In this white paper, we set out seven current challenges for the pharmaceutical industry, together with proposed solutions that will help companies to understand labeling in the context of these challenges. The potential impact from straightforward changes in labeling processes may be surprising to many in the industry.

Rising demand for fast response times in manufacturing has prompted the pharmaceutical sector to implement new data integration processes. Chief among them is integrating Manufacturing Execution Software (MES) and Enterprise Resource Planning (ERP) systems with a modern label management system.

Pharmaceutical companies have long seen the need to integrate labeling with their MES and ERP systems; however, most have hard coded labels inside these systems, a practice that requires extensive IT development and maintenance resources.

Modern label management enables a pharmaceutical company to integrate labels with the master data, digitize the entire label creation process and empower business users to handle change requests. This type of data integration enables pharmaceutical companies to address a number of label management issues, including:

For pharmaceutical companies, regulatory compliance is a part of doing business. Government regulations such as FDA CFR 21 part II, Eudralex Annex 11 and GAMP 5 require companies to ensure the security and accuracy of their electronic records, as well as prove compliance with GMP. In addition to the need to comply with governmental authorities, pharmaceutical companies also have to submit to audits from business partners and customers.

Failure to comply with the standards of any of these requirements can have catastrophic consequences for a pharmaceutical company’s business and reputation. With a legacy approach to labeling, meeting federal or international requirements often required a lot of manual overhead and paperwork. Adopting a modern label management system and digitizing label storage reduces manual processes, improves label quality and streamlines compliance procedures. Modern label management does this by enabling centralization, label lifecycle management and audit trails.

Pharmaceutical companies that have implemented a modern label management system have found that their data quality has improved and the time and effort spent on compliance have reduced dramatically.

This is achieved through consolidating existing label files into a series of intelligent universal templates, which, in turn, dramatically simplifies label management and reduces the number of change requests.

Implementing a modern label management system also places pharmaceutical companies in the best position to respond to future requirements, such as serialization. Increasingly, each pack of tablets, each bottle of medicine and each box of any pharmaceutical product will have a unique serial number, enabling it to be tracked and traced. This is partly an anti-counterfeiting measure and also assists in improving safety and accountability in the industry. By using one label management solution for both labeling and direct marking printers, pharmaceutical companies will be able to meet the demands serialization will place on their business. Through printing barcodes for individual boxes, cases, pallets or any other pharmaceutical packaging, regulatory requirements can be fulfilled and products tracked and traced.

One of the main goals behind the regulations governing the pharmaceutical industry is ensuring consumer safety. For example, part of the intention behind the DQSA regulations is to reduce potentially costly and life-threatening errors and oversights. The regulations are the latest development in a long-standing process through which the FDA and the equivalent organizations in the European Union have sought to protect public health. Errors in prescriptions or doses due to inaccurate labeling can cost billions of dollars and thousands of lives. Thus, product identification standards have been drawn up in order to ensure patient safety through obligatory validations, audit trails, electronic signatures, copies of records and record retention. This place labeling standards at the heart of pharmaceutical companies’ efforts to maintain safety standards eliminate errors and guarantee accuracy.

A modern label management system should be efficient, accurate and able to operate without paper versions of records and designed to work across an entire organization, managing the complete label lifecycle. This approach, where data is controlled and managed throughout the label lifecycle, is especially relevant for pharmaceutical companies, as products move from the factory to distribution and through various packaging iterations. Keeping track of the progress of a product so that it remains safe and can be delivered to its intended destination is of critical importance. Labeling is an integral part of this process.

Beyond issues of human health, pharmaceutical companies have to beware of the threats from counterfeiters and from agents diverting pharmaceutical products. A label management system that includes a central document management system helps with the fight against these twin issues, since it is easier to secure label files and provide multiple levels of role-based security to limit access to data.

With tighter margins across the pharmaceutical sector, cost saving has become a central issue in the industry. Also, here a modern label management system can be of assistance by helping companies create faster, more efficient operations throughout their production process, from manufacturing to order fulfillment.

For example, if a large-scale manufacturer is able to label its goods more quickly, accurately and with better traceability, it will also be able to ship these goods and sell them more quickly.

In addition to the direct cost savings that can be achieved through efficiency measures, a modern label management system helps to reduce and eliminate the losses caused by unplanned production delays and product re-working as a result of labeling errors.

In other cases, costs can be reduced simply through minimizing label variations and preventing duplication. By moving from printer code or printer-specific label formats to universal intelligent label templates, KRKA, a European generic pharmaceutical company, was able to eliminate a high volume of duplication, creating significant cost savings through saving hundreds of hours spent on label change requests.

There is a common-sense calculation to cost savings in label production: if a company has a decentralized labeling operation, each facility that ships products to customers must update its label templates whenever a new element is introduced. This will include adding new fields to a label template, adding new barcodes and so on. In many cases, IT staff will be involved in these changes, at a high cost to the organization. Alternatively, label design and amendment may be sub-contracted to an outside agency, with further cost implications and potential time delays.

By contrast, a centralized, modern label management system helps to reduce direct and indirect costs through minimizing the labor, time and expertise required to maintain label formats, make changes and create new labels. The repetition and redundant effort present in a decentralized labeling operation can be eliminated, freeing up IT staff for more productive work and saving hundreds or even thousands of man-hours, along with vast amounts of money.

Customers and the markets in which they live are becoming increasingly involved in how products are labeled and shipped and are, in many cases, placing demands on pharmaceutical companies that they cannot ignore. Added to this are the demands of meeting local and regional requirements for labeling that international pharmaceutical companies must face.

To adequately meet the demands of so many different stakeholders, pharmaceutical companies need to be agile and capable of meeting new requirements quickly. Modern label management systems enable this responsiveness and help companies manage the complexity of location-specific labeling requirements, while maintaining consistency and efficiency.

A modern label management system will include a centralized document management system and the capacity to scale standardized processes across an extended global supply chain.

Such a system should also be able to connect with MES and ERP systems and facilitate data integration programs. Adopting this approach will make a labeling system more responsive to enterprise demands.

Many manufacturers today contract some of their production to third parties. Whether companies choose to integrate contractors into their ERP system, or elect to extend their labeling platform to contractors via web printing, a modern label management system will ensure that the labeling process remains consistent across all sites.

Effective supply chain management is a central element of 21st century commercial life. Pharmaceutical companies have to collaborate with business partners in even more complex ways, across geographical and product boundaries. Deploying a modern label management system can help them achieve consistency and efficiency in these partnerships.

Using the latest generation client-side web printing labeling 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.

Centralized labeling systems make the whole extended supply chain more responsive to change requests and deter diversion and counterfeiting through advanced labeling techniques.

By making use of web-enabled technology, modern label management systems also improve internal collaboration by making it easier to deploy the system to business users across departments, offices and sites. Using a browser-based interface enables shop-floor users to access and print centrally-managed labels and data, thus improving label and brand consistency while reducing mislabeling. Having a web-based system is also the best way to manage a multiuser environment, and provides the transparency, tracking and access control highly-regulated environments require.

Since the dawn of globalization, every international company has had to deal with the global vs local dilemma: to what extent should a company centralize or localize key operations? For pharmaceutical companies, centralization means being able to improve consistency, accuracy and accountability. However, the vast amount of local or regional regulations and requirements can make centralizing labeling a challenge. Pharmaceutical companies also seek to mitigate the risk of downtime in their production operations by spreading production centers and their data and labeling functions, between different locations. Thus, there is also a compelling argument to be made for decentralizing labeling.

A modern label management system allows for both options, enabling pharmaceutical companies to select the configuration that best suits their business, products and processes. Modern label management systems adapt to the IT layout of the company in question. If a company has a centralized ERP (SAP) system, then they will most likely choose a centralized label management system.

If they have decentralized MES, then they can use the same system to decentralize label management, while still benefiting from some aspects of centralization.

As this white paper has outlined, implementing a centralized, modern label management system offers pharmaceutical companies the opportunity to make profound improvements to their business processes, reaching far beyond label production.

When successfully implemented, a modern label management system can yield dramatic results, including:

• Increased efficiency and streamlined compliance.
• Greater label consistency and customer responsiveness.
• Label template consolidation and a reduction in change requests.
• Improved governance for label content and layouts.
• A scalable platform for future growth.

Agility, accuracy and compliance will be hallmarks of successful pharmaceutical companies going forward. To compete and thrive in an increasingly complex and challenging marketplace, pharmaceutical companies will have to rethink their processes and find ways of accomplishing more with less. This transformation starts with implementing a modern label management system.

About Nice Label

Nice Label is the leading developer of label management software solutions for the life sciences industry. Our solutions enable pharmaceutical and other life sciences companies to realize the benefits of modern technology for all of their variable label and packaging printing. Through its headquarters in Europe and global offices in Germany, the USA, Singapore and China, Nice Label provides its clients with the best technology that delivers ROI that exceeds expectations.

The old axiom is as true as it ever was, but in today´s business environment, strategy planning cycles must be more rapid, dynamic and agile than in the past. Empower program delivery teams to experiment and learn in an environment where it is safe to fail fast. Discuss challenges openly and adjust the plan as needed for success. Learn to reward failure or at least acceot it as a valuable input.