Adding to the complexity of drug-product labeling, companies face a broad range of evolving requirements. Those include regional, language, customer, and regulatory requirements that must be met quickly and efficiently to prevent supply-chain disruption. Companies that cannot meet those requirements can end up with fines, dissatisfied customers, and loss of business. Enterprise labeling solutions allow drug makers to deal with variability in labeling by providing label formatting that supports myriad different label combinations with a minimum number of label designs.

Major Drivers Causing Labeling Variability
A number of issues can lead to variability in labeling, but the primary drivers are customer variability and regulatory requirements. No standard label works for every situation. Customers are becoming more demanding about the labels that appear on goods and products that they receive, distribute, and sell. The same standard product might have a product label that varies greatly based on the unique requirements of its intended customers in different places. Although the product itself remains the same, its label might need different data, images, or other information to meet customer-specific criteria.

Regulatory requirements also drive variability across a broad set of industries, including those producing chemicals, food and beverages, medical devices, and pharmaceuticals. Manufacturing locations and shipping destinations are factors that further complicate labeling because each country or region has specific regulatory requirements. For example, health and safety information must be in both the language of the country of origin and in the languages of countries where a product will be sold. Also, some products may require compliance logos (such as the RoHS logo for electronics). So the product itself can dictate additional labeling needs.

Variability Can Negatively Affect Business
Companies have to address labeling variability one way or another, whether through manual labor or computer automation. For manual labeling, companies need to apply labels addressing specific customer requirements directly to each product or make sure that each product and its variants have labels prebuilt (printing a range of them for use depending on where a product is shipped). Either approach will obviously involve a significant amount of time and effort.

Clearly, labeling variability will have a significant effect on drug-makers’ business. It can increase costs through manual-labor–intensive process complexities, ultimately resulting in time-to-market problems. When it is necessary to manage a labeling process manually or produce multiple label permutations, time becomes a factor that can slow production and delay shipments, resulting in fines and/or dissatisfied customers. If variability isn’t addressed, then products and shipments can be denied or even pulled from customs because of incorrect and/or noncompliant labeling. Also, the risk of mislabeling is higher when companies use manual processing to manage extensive variability, potentially leading to delays and fines.

Configurable Business Logic
Business logic is programming that manages communication between an end-user interface and a database. Many programs allow some customization of this process. Configurable business logic allows users to address changes or new requirements without having to extensively reprogram their corporate systems. If they already have all the information they need, users can simply update their processes. Companies can address each particular requirement for a labeling solution without affecting other business systems, and they can do so quickly. Configurable business logic also is critical to reducing the number of labels that a drug maker has to manage by allowing dynamic changes made to templates rather than requiring new templates for every variation of a label.

Enterprise Labeling Solutions Can Help
Implementing an enterprise labeling software solution automates product labeling processes, enabling drug makers to dynamically change label contents and easily manage regional, language, and customer-specific requirements. With this approach, users can make necessary changes without having to involve information technology specialists in the effort. Fill–finish groups can deal directly with their customers and meet regulatory and/or customer-specific transactions in a timely and less labor-intensive process. Label changes and updates can be made in hours or days rather than months so that delays are minimized. This cost-effective approach shortens time to market.

A good enterprise labeling solution offers symbologies, tools, and integration of regulatory data to ensure that the needs of each customer will be met. Centralized label management ensures that a company’s labeling process is consistent and adheres to regulatory guidelines throughout its global supply chain. The automated approach also reduces the threat of mislabeling.

Mike Ward is vice president of technical services at Loftware, 166 Corporate Drive, Portsmouth, NH 03801; [email protected].