Pharmaceutical companies continue to adapt to regulations like the FDA's Drug Supply Chain Security Act (DSCSA) and 21 CFR Part 11. At the same time, their supply chains need to operate more efficiently to compete in a growing marketplace. That’s why manufacturers are looking at labeling to provide an edge in the face of these challenges.
The pharmaceutical supply chain is highly complex, with many steps, as ingredients are often shipped in bulk, repackaged and reshipped, before they find their way to the manufacturer producing the branded end-products. Multiple tiers of suppliers and wholesalers are often involved. Oftentimes, borders are crossed. Labeling is essential to smooth the flow of the pharmaceutical supply chain, where problems can arise at any juncture in the chain, or may “wait” to become manifest only in a finished product.
A centralized approach to labeling allows companies to integrate the labeling process with their existing ERP, PLM, or other validated environments to drive data from “sources of truth,” which offer greater control. By using a central database, companies can avoid the need to replicate data, which reduces errors and offers improved labeling consistency for deployment to other plants and distribution partners internationally. This ultimately provides a new level of consistency, simplifies troubleshooting and streamlines labeling, helping to drive greater supply chain efficiency.
When labeling is integrated with the enterprise business processes rather than in a stand-alone system, processes can be simplified and non-value added activities, such as regulatory updates, can be reduced.
Meeting Regulatory Demands
The global nature of the pharmaceutical industry—with worldwide manufacturing and markets—means that complex regulations are growing around the globe. In addition, the GS1 System of Standards is aimed at improving supply chain efficiencies in numerous industries, including pharmaceuticals, and these standards are continuously evolving.
In the U.S., the Drug Supply Chain Security Act (DSCSA) is designed to create a system that can trace pharmaceuticals throughout the supply chain so that legitimate products can be verified, illegitimate products detected, and product recalls facilitated. Provisions of the DSCSA cover all parties in the supply chain, including manufacturers, wholesaler drug distributors, re-packagers, and dispensers. All stakeholders share responsibility for securing the pharmaceutical supply chain to protect providers and patients, and to guard against mishandling of products through counterfeiting, gray marketing and diversion.
However, a comprehensive enterprise labeling solution enables pharmaceutical companies to rapidly respond to changing regional and international regulatory requirements for labeling, including those being established by DSCSA. By leveraging a built-in business rules engine, companies can support labeling variations using configurable rules in a controlled manner, removing the risk of manual errors and mislabeling. Using data-driven label content and configurable business rules provide the flexibility to address requirements quickly while minimizing validation and approval activities necessary to implement label changes into production.
In addition to compliance with the DSCSA, there is also the FDA’s Title 21 of the Code of Federal Regulations (CFR) Part 11, which provides guidance for electronic records and e-signatures to streamline workflows. Here again, an enterprise labeling solution offering workflow and e-signature capabilities can provide a new level of visibility and control for managing labels in the highly regulated pharmaceutical and medical device industries.
Dealing with Constant Change and Increasing Customer Demands
Organizations within the pharmaceutical supply chain are increasingly required to respond to their customer and partner labeling demands. These requirements are varied: 2-D and linear barcodes, serialization, updated regulatory symbols, logo placement or other branding demands, language variations, location-specific information, country-specific regulations, labeling that enables healthcare providers to better monitor patient care ,and more. With enterprise labeling, pharmaceutical manufacturers can quickly respond to customers’ requirements, reducing what was once a month-long process to a matter of a few days.
One company in the pharmaceutical chemical space relied heavily on orders obtained through their website. The issue was that the formulations could change frequently but their labeling system wouldn’t always reflect the changes in time for shipment, causing a major issue with their customers. The company had struggled with this issue for years. With an enterprise labeling solution in place, they were able to change the data for their product, which automatically changed the label in real time. Standard labels, templates and systems allow for global compliance and a single source of the truth for change management.
Enterprise labeling can help smooth the flow within the drug supply chain, where problems can arise at any juncture, or may “wait” to manifest in a finished product. How quickly and accurately companies respond to customer requests or meet changing regulatory requirements such as DSCSA can mean a huge difference in time-to-market, customer satisfaction and cost savings.
Eliminating Delays and Delivering Measurable Savings
In a recent survey conducted with about 200 manufacturing professionals (including many from the pharmaceutical industry), nearly half—47%—indicated they were experiencing costly downtime due to labeling disruptions. The reasons cited for these delays included dealing with customer-specific labels, product-specific labels, and slow label printing speeds, in that order. When you add up all of these isolated labeling issues occurring across different segments of a supply chain, it can result in hundreds of thousands of dollars of lost productivity, severely impacting a company’s bottom line.
One pharmaceutical company, for instance, was managing several different label types—incoming materials, weigh-dispense, WIP, sampling labels, shipper box, pallets, finished goods—all of which have different layout and data requirements. With a goal of simplifying the labeling landscape and reducing the Total Cost of Ownership (TCO) for labeling, this manufacturer leveraged a centralized solution to pull data from trusted resources, improve accuracy, and consolidate and share templates across multiple sites. More importantly, they achieved their ultimate goal of simplifying their global labeling process and lowering overall costs.
Additionally, an automated process allows companies to achieve significant printing performance gains, allowing labeling to keep up with production. With this type of labeling platform pharmaceutical companies are able to initiate print jobs and produce labels anywhere in the global landscape. Labels are based on approved templates, using a common labeling infrastructure.
Creating Efficiences at the Supplier Level
For years companies in the pharmaceutical industry have struggled with how they integrate partners into their processes. Today many companies use third parties as extensions of their own business. When it comes to labeling, companies handle third parties in multiple ways, but the best way is to integrate the third parties into the labeling systems.
Using a secure partner portal or a secure enterprise labeling system, pharmaceutical manufacturers can allow suppliers to access and print labels locally—with the right information expected by the receiving organization. Globally consistent labeling can help reduce the need to manually ship labels around the world and can eliminate the need to relabel inbound shipments, which can save time, labor and money while reducing the likelihood of errors. Companies can set up this solution in a secured environment so third parties access information, labels and the printers only they are supposed to see.
Managing Growth and Expansion with Enterprise Labeling
Entering new markets is essential for pharmaceutical success. It’s where you’ll find many opportunities for growth, but each new market presents unique labeling challenges, as pharmaceutical companies must satisfy local language, shipping and regulatory demands. We discussed the value of pulling data from sources of truth like ERP systems, but a change like this may require programming which can take four to six weeks to complete.
To overcome this challenge, look for enterprise labeling solutions that have built-in business logic that can streamline label changes. Business rules can be configured and customized within a standard user interface to update label specifications quickly and dynamically—be it language, branding, regional compliance—where they’re needed. This also removes a significant burden from IT to eliminate the need to maintain custom code or manage so many label designs.
For example, suppose you bring on a new distributor in Germany who wants to introduce your medical device right away to meet a huge customer opportunity. With configurable business logic as part of the labeling solution, select users can quickly pull up the template, translate the text to German, and add appropriate symbols and health & safety language without any delays. Product gets out the door within days versus weeks or months.
Labeling is complex, and today’s pharmaceutical organizations are faced with a range of evolving requirements that complicate the process—and leave many companies accepting outside changes and regulatory updates to the process as a cost of doing business. But it doesn’t have to be that way. Labeling can make a huge difference, enabling IT and supply chain decision-makers to overcome challenges, and provide their company with a distinct competitive advantage.
Laura Johnson is a life sciences expert with Loftware, a provider of enterprise labeling solutions.