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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 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? 

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