Executive Briefings

Is the Life Sciences Industry Living Up to Standards?

Robert Celeste, director of healthcare with GS1US, relates the group's efforts in establishing industry-wide standards for the life sciences sector.

GS1 is an international body that develops standards for around 23 industries. Celeste works in the healthcare and life sciences sector, where standards are of critical importance. In life sciences, they relate to three main areas: product identification, item identification and the marking of products with barcodes and aspects of radio frequency identification (RFID). E-commerce messaging is also a key concern. The idea, says Celeste, is to be able to standardize such areas, then share the information with trading partners.

Barcodes have been in use in the pharmaceuticals area for a long time, although the consumer goods sector is more advanced in the adoption of standards for marking products. Pharma is moving more quickly in areas such as tracking and tracing and electronic pedigree, Celeste says.

There are some major challenges to be addressed, especially with regard to new regulations in the state of California, which has set a 2015 deadline for serializing product and establishing the chain of ownership through e-pedigree technology. Every party that handles a product on its way to market is considered part of its lifecycle and must be identified as such. Federal regulators are developing similar requirements for tracking product throughout the supply chain on a national level.

In response, GS1 has launched a program to apply standards that will aid in the determination of product pedigree in the U.S. and elsewhere. The process will likely include numerous types of marking, including barcodes on bottles and RFID devices on cases and pallets. "Some countries will be a bit more difficult to comply and be interoperable," Celeste says. "It's a multi-year, multi-dimension effort."

To view video in its entirely, click here


Keywords: supply chain, supply chain management, global logistics, third party logistics, logistics management, supply chain solutions, supply chain planning, bio-tech supply chain, supply chain risk management, e-pedigree, GS1

GS1 is an international body that develops standards for around 23 industries. Celeste works in the healthcare and life sciences sector, where standards are of critical importance. In life sciences, they relate to three main areas: product identification, item identification and the marking of products with barcodes and aspects of radio frequency identification (RFID). E-commerce messaging is also a key concern. The idea, says Celeste, is to be able to standardize such areas, then share the information with trading partners.

Barcodes have been in use in the pharmaceuticals area for a long time, although the consumer goods sector is more advanced in the adoption of standards for marking products. Pharma is moving more quickly in areas such as tracking and tracing and electronic pedigree, Celeste says.

There are some major challenges to be addressed, especially with regard to new regulations in the state of California, which has set a 2015 deadline for serializing product and establishing the chain of ownership through e-pedigree technology. Every party that handles a product on its way to market is considered part of its lifecycle and must be identified as such. Federal regulators are developing similar requirements for tracking product throughout the supply chain on a national level.

In response, GS1 has launched a program to apply standards that will aid in the determination of product pedigree in the U.S. and elsewhere. The process will likely include numerous types of marking, including barcodes on bottles and RFID devices on cases and pallets. "Some countries will be a bit more difficult to comply and be interoperable," Celeste says. "It's a multi-year, multi-dimension effort."

To view video in its entirely, click here


Keywords: supply chain, supply chain management, global logistics, third party logistics, logistics management, supply chain solutions, supply chain planning, bio-tech supply chain, supply chain risk management, e-pedigree, GS1