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Advice for getting started with pharma serialization

The first thing manufacturers should do is: Hurry! But there's more...
 

If there's one issue driving pharmaceutical manufacturers and packagers to ramp-up their educational efforts, it's the need for compliance with item-level serialization. Requirements such as the California State Board of Pharmacy's E-Pedigree Law--if there are no further delays--will take effect on a staggered basis from January 1, 2015 through July 1, 2017 with the following schedule:
  • 50 percent of a manufacturer's products by 2015;
  • The remaining 50 percent of the manufacturer’s products by 2016;
  • Wholesalers and repackagers must accept and forward products with the e-pedigree by July 1, 2016; and
  • Pharmacy and pharmacy warehouses must accept and pass e-pedigrees by July 1, 2017.
At 2012 Pack Expo in Chicago, D. Bruce Cohen, principal, PackTechPlus, Raleigh-Durham, NC, presented some fundamental bits of advice from his industry consulting experience, including: "Hurry!" This is because only a call minority of companies have
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lines in compliance and there will be intense competition, and possibly something of a shortage for the outside consultants manufacturers will have to "rent.” And change doesn't come easy to manufacturing personnel when a "temporary" expert is brought in; these things take time.
 
Beyond "Hurry!" Cohen's fundamental advice is that "communication within your company is critical. Also, the effort "must be driven top-down" and involve all levels of personnel. This includes not just inside the manufacturing organization, but across suppliers, contract manufacturing organization (CMO) partners, wholesaler-distributors and retail distributors. 
 
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.

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