Brazil Works Out Elements of Its Plans For Serialization

Brazil’s schedule for establishing serialized packaging has been side-tracked, as industry debates what the program should look like.

The country’s regulatory authority, ANVISA, has outlined requirements for a traceability system, following national legislation that sets out an aggressive three-year time table for a full track-and-trace solution.

In the system, ANVISA will supply manufacturers with pre-printed labels serialized with GTIN 2-D Data Matrix codes and manage supply chain queries through a government-run data repository. ANVISA has called also for the addition of a holographic security feature.

Since the model was detailed last year, manufacturers have lobbied against provisions including that labels must be applied within the country. Labels bearing the coding, printed by the Brazilian Mint (CMB), were to be applied to all drugs in production as of January 2011.

Joseph Ringwood, COO, Systech International, says that the label application deadlines are presently on hold, as manufacturers have raised concerns over several issues. Questions include whether the labels can be shipped out of the country for applying to packaging and whether (and where) manufacturers would have to apply the labels.

ANVISA wants to tightly control the label distribution. Manufacturers are concerned that they will then have to relabel product exported from production facilities abroad. For applying labels locally, manufacturers would have to adopt a cumbersome “slap and ship” approach to imported products.

“Europe [for example] is the largest market importing into Brazil. The regulation is telling manufacturers they can’t do a finishing operation at the plant where the product is manufactured. And you can’t have a 3PL putting them on,” Ringwood says.
The pre-encoded labels are another point at issue. “Manufacturers wanted the choice of printing the labels on line. ANVISA at one point said the in-line printing would be acceptable. At this juncture, mandatory use of pre-encoded labels is back on the table,” he says.

Despite manufacturers’ preferences, ANVISA in speeches and written texts has not given any indication that they will depart from the orginal regulations, says Peter Schmitt, managing director, Montesino (Wilmington, DE).

“ANVISA is saying ‘we’ve got to do it right, it’s complex, CMB has a lot of work to do, so we will allow for more time to do it right,’ ” Schmitt says.
As manufacturers push for changes in the regulations, they have held back on technology investment. “The thought is that the requirements will be clarified in the near future,” Ringwood says.

In the system, manufacturers will report to ANVISA on valid numbers on packaging shipped into the marketplace. Facing later deadlines, wholesalers and pharmacies will need the ability to read the codes and query the government data base for validating good product.

Systech announced a partnership earlier this year with Videojet Brazil for preparing manufacturers to meet the anticipated deadlines in South America’s largest pharmaceutical market. Videojet Brazil will sell, install, and support Systech’s serialization solution in the country.

With Systech’s Serialized Product Tracking (SPT) solution, the company provides configurable software with the capacity to flexibly handle multiple coding schemes, and conform production to varying country requirements and changes in regulations.
The solution supports cost-effective re-validation when new codes have to be used or lines reconfigured to meet the varying  requirements. As a productized—or ready to be installed solution—Systech SPT is quickly deployed as a replicable solution across plants and countries.

“Regardless of what schemes countries may adopt, with Systech SPT, the architecture is in place to meet any change in regulations,” Ringwood says. “This allows manufacturers to begin planning, implementing, and testing a few initial lines in preparation for upcoming regulatory delivery dates instead of waiting for final confirmation and scrambling for a solution.
“Keep in mind that the regulations will not dictate the on-line and off-line packaging workflows. Only the data format and data carriers will be affected by the regulations,” Ringwood says.

Systech SPT supports modeling real world process flows. Systech has developed a library of process streams that are wrapped into redeployable packages for specific use cases. When new labeling and packaging requirements arise, these proven composites are dropped into the work flow. Using this architecture, manufacturers can manage changes to data carriers (pre-printed or on-line printed labels) and data formats (bar code contents and human readable text) through configuration instead of software development.

“If you are adding product for Korea with a different numbering scheme on a line running product for Brazil, or adding a second SKU on a line that needs a different label and positioning, flexible reconfiguration becomes highly desirable.
“Using our configurable software approach (GAMP Category 4), companies can avoid the inherent risks associated with writing, validating, and maintaining custom software. Validation protocols can be significantly less cumbersome and less costly,” Ringwood says. ■