Retooling for Regulatory Compliance

Published on: 
Pharmaceutical Technology, Pharmaceutical Technology-09-02-2006, Volume 30, Issue 9

Now is the time to get ahead of the learning curve and explore options for meeting pedigree guidelines.

The US Food and Drug Administration recently announced stringent guidelines to prevent and detect counterfeit drugs, including plans in December to discontinue its hold on the Prescription Drug Marketing Act (1987), requiring pharmaceutical companies to collect and maintain data about the pedigree of their drug products.

FDA's pedigree guidelines require data capture at each stage of the process until the drug products reach end users. These data can be provided by the manufacturer, by the distributor, and by the agency or store dispensing the drug.

Sharad Vajpayee

From a manufacturer's perspective, the guidelines require companies to maintain data on each case that leaves the shipping dock. This information includes, but is not limited to: brand name and product identification; manufacturing, shipping, and expiration dates; corporate and manufacturing addresses; and quantity, weight, and lot number of the case.


Effective pedigree software uses existing enterprise resource planning data and a flexible mapping process to extract and format data. For example, at one drug manufacturing site data are captured in a separate pedigree database as production is completed. A software integrator tool greatly simplifies the mapping of external data into the database and should not require technical programming.

As cases are prepared for shipment to the customer, a unique 18-digit ID is generated. Just before being placed on the truck or pallet, a bar-coded label or radio frequency identification (RFID) ticket is generated for each case, which, among other information, incorporates the unique pedigree ID.

The 18-digit pedigree ID is the key link between the case and the pedigree data. The first five digits designate the manufacturer and are assigned by the EPCglobal. The next 12 digits is a sequential number with the 18th digit being a check digit. In situations in which both parties use electronic data interchange, the ID can be included with the advance ship notice (ASN); otherwise an external file containing the same ID must be used to transmit the information. As the cases are received, the label is scanned and the unique pedigree ID is compared with the ID contained in the ASN. Mismatches could signify a counterfeit situation.

Whether barcode labels or RFID tickets are used depends on the manufacturer's and the customer's technology and equipment. From a software perspective, writing labels or tickets requires the same level of effort. Few pharmaceutical companies have RFID technology fully deployed in their warehouse. Some manufacturers only have one or two customers who demand RFID compliance. These manufacturers use the "slap-n-ship" technique (i.e., the ticket is printed and slapped on the case just before shipping) to implement RFID. RFID tickets are generated based on the ship to customer as well as at the end of the process.

An external, bolt-on pedigree solution is preferable because there would be no need to modify existing applications or manufacturing processes. Some minor customization may be required to the format and sequence of data, so the reporting module should be flexible.

Soon, most states will require compliance with the pedigree guidelines. Now is the time for pharmaceutical companies to get ahead of the learning curve and explore options for meeting these guidelines.

Sharad Vajpayee is the vice-president of ORION Software for 3i Infotech Inc., tel. 732.512.2473