PFFC - January 2009 - (Page 39)

BRAND SECURITY Making Preparations Converters should expect more questions about mass serialization and e-pedigree from pharmaceutical customers in the coming months and years, so the best rule of thumb is to contact a mass serialization supplier to learn about the solutions it offers. Converters should invite representatives for a site visit and ask questions that will ascertain the supplier’s understanding of converting. A converter that already has faced a question or even a mandate from a key customer should be prepared with data such as the following: u The customer’s exact requirements and timeline for implementation; u The type of variable data to be applied; u The tolerance for implementation downtime; u The source of the variable data, including unique product identifiers. For example, will codes come from the customer or from the solution’s codegenerating software? Being prepared can reinforce a converter’s partnership with that pharmaceutical customer. JANUARY 2009 | 39 This is a screen shot of software designed to generate unique codes to be printed on cartons and labels by a converter. California e-Pedigree Law According to the California law, an e-pedigree is “an electronic record containing information regarding each transaction resulting in a change of ownership of a given dangerous drug, from its sale by a manufacturer through acquisition and sale by one or more wholesalers, manufacturers, or pharmacies, until final sale to a pharmacy or other person furnishing, administering, or dispensing the dangerous drug.” A pharmaceutical manufacturer is required by the California law to have one-half of its product lines serialized by Jan. 1, 2015, with all lines serialized by Jan. 1, 2016. While several other states have their own e-pedigree legislation, California’s is the most stringent. It includes preemption language so its requirements will mirror those of the federal government when a national e-pedigree law eventually is developed. WWW.PFFC-ONLINE.COM The California law states that a “specified unique identification number” is required for e-pedigree purposes. Such a unique product identifier, typically a two-dimensional (2D) DataMatrix bar code, can be essentially a digital “fingerprint,” assigned uniquely to a given product package. This code becomes the means to track that individual unit throughout the supply chain by “marrying” that unique code to its shipping box and pallet. The code is also one of several types of variable data that a converter should be prepared to print on a carton or label when asked by a pharmaceutical customer. Other types of data include the following: Integrated Mass Serialization Components in a mass serialization solution must be tailored so the entire process of generating, printing, and verifying codes, as well as accumulating supply chain transaction data, is seamless for the converter. Those components include the following items: u Software should generate codes like 2D DataMatrix unique product identifiers and maintain a master database that compiles future transaction information. Codes also can be generated by the pharmaceutical customer and loaded onto the converter’s variable u A Global Trade Identifier data printer. Number (or GTIN), u A line controller should which includes information interface with the line’s about the product variable data printer and and manufacturer; camera system to manage u Lot or batch codes and the codes that are printed. expiration date, which u A variable data printer, typically are human-readable. such as a small character http://WWW.PFFC-ONLINE.COM

Table of Contents Feed for the Digital Edition of PFFC - January 2009

PFFC - January 2009 Contents First Glance Calendar of Events From the Editor Web Lines Process Management News Clips Narrow Web & Label Reporter Narrow Web & Label What’s New Products In-Mold Labels Cover: Ink Trends Economic Outlook Brand Security Show Preview What’s New Products Services Directory Classified Marketplace Equipment Buyers & Sellers Advertisers Index Experience Speaks

PFFC - January 2009

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