Not just ‘why,’ but ‘how’

Miracles still happen. In the fall of 2013, the U.S. House of Representatives and Senate passed the Drug Quality and Security Act (DQSA), a bill that will regulate compounding pharmacies and would impose a phased-in nationwide serialization and e-pedigree regulation.

If the DQSA is signed into law by the President, as most expect, several things will happen right away. First and foremost, all current state and federal serialization and pedigree laws (yes, including California) will be preempted. This will result in the elimination of the frequently discussed “patchwork” of U.S. drug pedigree laws in one fell swoop—to be replaced with a single approach to supply chain security as outlined in Title II of the DQSA.

So the “why” of drug serialization may have become clearer, but the “how” is still a challenge. Success in both strategizing and implementing a serialization program can only be guaranteed with a structured approach where all stakeholders are on board from the beginning—not just at the execution stage.

This Playbook from Healthcare Packaging is your roadmap to achieving serialization success. It will arm you, not only for meeting e-pedigree requirements, but also for convincing top management to start a global serialization program NOW for complete visibility into your supply chain, and to reap the resulting business benefits.

The Playbook doesn’t make decisions for you, but it will detail your choices, and offer best practices and lessons learned. We have reviewed the vast quantities of published serialization information (and discarded outdated findings), tapped into consultants, systems integrators, hardware and software suppliers, and end users, and polled our readers to get a feel for where they are in the process—all to bring you this Playbook.

This Playbook is a resource to be shared with the entire team. We discuss the team, and how each step of the project impacts every department—line-level machinery and controls, plant operations, package design (label and panel management), IT’s role for plant-level manufacturing execution systems (MES) and organization-wide ERP—and those outside your organization—the trading partners who must be prepared to “read” whatever you send them. Serialization of pharmaceuticals is complex, and all-encompassing, and it impacts every aspect of the organization. In fact, experts recommend combining other major organizational changes to coincide—new machinery purchases, software updates, physical plant relocation or expansion, etc. Updates for serialization and traceability also offer an opportunity to improve operational efficiencies by refining processes and documentation.

Let’s start with a legislation update.

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