CMOs scramble to get DSCSA compliance in place by November

Multinational pharma companies have been preparing for the imposition of 2D-barcoding and traceability rules (under the Drug Supply Chain Security Act, or DSCSA) for years, and while few are 100% compliant today, few are also unaware of a looming November deadline for having the barcodes in place on the packages they put into commercial distribution. The picture is somewhat different among contract manufacturing/packaging organizations (CMOs); besides the fact that their traceability technology needs to meet a variety of pharma client requirements, they are generally more resource-constrained than Big Pharma, and need to make such capital investments carefully.

As a practical matter, the day has already passed for getting a compliance program started and in place by November; industry experts say that it takes roughly 18 months to spec out requirements, design a system, set out equipment RFPs, then install, test and qualify the system. In any case, it’s better to have something, if not a full-blown compliance system, in place in November for FDA inspectors; the agency has been employing “regulatory discretion” at many steps along the DSCSA pathway, and is likely to do so going forward. With that in mind, at least two of the vendors of packaging line serialization equipment and software are now offering quick-start programs especially for CMOs. Both will be on display at the Interphex trade show, set to start on March 21 in New York.

A pioneer in the pharma serialization field, Systech International, which offers both machine vision systems and enterprise-level software, announced a “Serialized by November” program, which it claims can get basic DSCSA compliance in place in 90 days. This includes “multi-level serialization; site and line management configuration; a built-in foundation for future lines, Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT). Systech is currently onboarding customers from now until August 1, 2017. The company also claims 1,600 existing implementations (which could include multiple packaging lines at some clients), said to be “65% more lines than its next largest competitor.”

Optel Vision, which also claims market leadership in this space, has announced the Fast Series, a line of preconfigured traceability products designed, as it says, “to accommodate various product sizes, speeds and print locations,” which would be helpful to both pharma brand owners and to their CMOs. Optel claims delivery in as little as six weeks. The company says that a Fast Series unit comprises a simple and convenient user interface with clear operational instructions, and can be integrated with Open SiteMaster, the company’s Level 3 (site level) data-management system. Fast Series units are a variety of labeling or packing stations that can be wheeled into place on a packaging line: PackStation, LabelTracker, CLTracker and others.

A couple weeks after Interphex, a consulting firm operating in the traceability market, Supply Chain Wizard, is sponsoring a meeting on April 4-5, "Pharma CMO Summit," in Princeton, NJ. Solution providers Adents, Antares Vision, Verify Brand, along with several pharma manufacturers and the Pharma & Biopharma Outsourcing Assn, a trade group. More information is at PharmaCMOSummit.com.

Getting the DSCSA-compliant label on a package is a necessary first step—but needs to be followed by managing the storage and transfer of serialization data to trading partners, and eventually applying some business intelligence to warehousing, inventory and distribution practices overall. But it’s a start!