How Labeling Helps Meet Pharmaceutical Supply Chain Challenges
The pharmaceutical supply chain is highly complex. Many 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 offers 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.
The Drug Supply Chain Security Act (DSCSA) is designed for traceability so that legitimate pharmaceuticals 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.
A comprehensive enterprise labeling solution enables companies to rapidly respond to changing regional and international regulatory requirements for labeling, including those being established by DSCSA. Manufacturers can support labeling variations by using configurable business logic while removing the risk of manual errors and mislabeling. Using data-driven label content and configurable business logic provides the flexibility to address requirements quickly while minimizing validation and approval activities necessary to implement label changes into production.
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 it’s commonly a manual process wrought with inefficiencies and difficult to manage consistently at remote locations. Many manufacturers rely on third party printing companies to produce and ship the labels directly to the partner or they pay to have the labels printed by an outside vendor after receipt of an order. These options can be extremely costly and can cause significant delays and mistakes, especially when you need to take into account ongoing regulations like DSCSA. The best way to handle this challenge is to integrate the third parties into the labeling systems.
Using a secure partner portal or a secure enterprise labeling solution enables suppliers to access and print labels locally with the right information expected by the receiving organization. Globally consistent labeling reduces the need to manually ship labels around the world and eliminates the need to relabel inbound shipments, saving time, labor, and money while reducing the likelihood of errors.
Labeling is complex; 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. 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.