Advice for getting started with pharma serialization

 

Get your pilot started

So where should companies start? "Do all your design work on one line," he says. A company can't know the specific impact that serialization will have on its operation until a pilot test. By picking one line, perhaps a relatively small or simple line, the company can work-out its standard operating procedures (SOPs), and deal with the realities of managing serial numbers already assigned to labels or packages that are damaged or lost due to jams, damaged product on the line and non-reads. For example, what happens if there's a jam and a labeler goes down? 

 

Similarly, companies need to establish SOPs across the supply chain in order to properly track returned goods and recalled product. "If you have return goods within your own 'walls' you can manage those very well," Cohen explained, but when it comes to outsourcing partners, there have been cases where five percent of returned goods have none been the manufacturer's product at all.

 

Ask contract manufacturers & packagers

On contract manufacturing organizations (CMOs), the key advice Cohen gave is: "You've got to talk to them, learn from them… They are, I'm sure, way ahead of you because…they have to be able to serve multiple customers." All a CMO needs is one pharma customer they can't afford to lose, and they'll have serialization expertise all the other customers can capitalize upon.

 

Outsourcing partners provide a valuable service to companies who have no in-house manufacturing, packaging and related resources of their own, but they also must remember to be flexible with regard to product codes. Cohen says he has "been fighting" with some in the business to avoid "hard coding" packaged units; the product may comply with serialization requirements, but "a product code needs to be changeable to meet customer needs." For example, a given product may be the same for multiple customers, but each should be able to have its own product code that fits each customer's system. There has been at least one case where a customer--a pharma brand--had to settle for its contract service provider's codes because it would have taken eight weeks to make a customer-specific change. 

 

Consider your IT strategy

Different types of codes may be required for presenting a package's ID or Standardized Numerical Identifier in accordance with the global GS1 standard, whether because there are multiple, valid paths to a solution or because not all supply chain partners will be able to implement a single standard. Three main types of codes support the all GS1 identification numbers including the required identifiers: linear bar codes, data bars (formerly called RSS or reduced space symbology) and 2D codes such as the Data Matrix, for which image scanners replace the linear scanners that can be used to read the other two formats, which are more limited in the data they can practically carry. Certainly there are many choices, some of them half-steps, as in the case of using coding schemes that incorporate more than one kind of code to accommodate supply chain partners. 

 

But coding, scanning, vision and related processes and technologies are relatively straightforward. Beyond them, "all the rest is IT," or information technology, Cohen says. Requirements are diverse requirements for pending laws from California as well as across the United States and the globe. This gives rise to more IT questions, and a need for flexibility. For example, companies can manage their own coding databases or have an outside vendor generate serialization codes and handle database management.