Decoding product traceability

The FDA has already announced a review of its 2004 drug barcode rule that requires drug companies to print a linear barcode containing the product’s National Drug Code (NDC) directly on the pack or label. The eight-year-old FDA rule was born of a concern that too many hospital patients were receiving the wrong drugs. The hope then was that hospitals would scan incoming drugs, eventually at a patient’s bedside, to ensure correct medication. But since the rule went into effect in 2006, a second concern – counterfeit drugs – has gripped the FDA and some EU countries.   

The counterfeiting of Roche/Genentech’s Avastin ratchets that concern up another notch since counterfeits had been predominantly restricted to bogus pills.    

California is way ahead of the FDA in erecting defences, having enacted an e-Pedigree requirement to force pharmaceutical companies to include a unique serial number, lot number and other information inside a barcode so that the individual container can be ‘tracked and traced’ up and down the distribution chain using scanners, software and databases.   

Pharmaceutical manufacturers who wish to comply with the Californian law will have to use a tiny, two-dimensional (2D) GS1 DataMatrix barcode on packages instead of or in addition to a linear barcode.    

DataMatrix (usually based on the global GS1 standard) is now required in Argentina, France, Turkey, Korea and India.

Talking to South African FMCG manufacturers and suppliers of coding, marking and labelling (CML) equipment and consumables, it’s clear that ensuring the correct code is applied in the correct location on the correct product and packaging is essential for reducing risk, costly product recalls and costs from product rework.

Where product coding was once primarily about printing ‘sell-by’ dates on foodstuffs, it’s now an essential element of supply chain management for retailers. It’s also rapidly – via the use of QR codes and smartphone scanners – becoming a marketing tool for brands to interact with consumers about product information or to find out more about the products consumers are buying.

In the following pages, a number of trends are revealed. CML equipment now offers better integration capabilities, centrally managing different coding technologies (ink jet, laser, thermal transfer and print and apply) used for primary, secondary and tertiary coding.

Not only has packaging become more graphic, but this trend also extends to coding equipment with machine manufacturers incorporating more graphically-based touchscreens to simplify operation and maximise productivity and control.

Software for code assurance, such as Videojet’s CLARiSUITE (see p83) is also gaining popularity for simplifying message selection. Studies reveal that up to 70% of coding errors are caused by operator error, with almost half caused by mistakes in code entry and job selection.

Another common thread is the need for CML equipment to withstand harsh industrial environments.

Some of the wide array of CML options are featured.