Vetter, a contract development and manufacturing organization (CDMO), now offers the option of clearly identifying packaging used for drugs. Vetter’s comprehensive and flexible serialization service is in response to stricter guidelines from the regulatory authorities of many countries aimed at combatting counterfeit drugs. Pharma and biotech companies can use Vetter’s individually customizable solutions as a basis for their own track-and-trace programs to optimize their supply chain.
The number of counterfeit drugs on the market is growing and has quickly become a serious global challenge, putting patients at considerable risk, and costing the pharmaceutical industry a significant amount of money. Lawmakers and regulatory agencies around the world have responded by creating new guidelines to increase drug safety. Government and industry both agree that the best available solution is tracking and tracing drugs from production to distribution, on through to the dispensary or the pharmacy. The key to reaching that goal is serialization and Track-and-Trace; the distinct identification of the smallest packaging unit with a unique identification number.
In some countries, like Turkey, India, China, and Argentina, regulators are already calling for drugs to be serialized. Many other markets will be following suit in the coming years, including South Korea, Brazil, the U.S, and the EU. The requirements and specific serialization guidelines however, are country specific, which is why pharmaceutical companies operating internationally need flexible solutions to meet these differing requirements. That is why Vetter offers various options for the serialization of drugs. These include making available different serial number and code formats, interfaces and reports or various aggregation depths. And there are, of course, national differences that must be taken into account. South Korea for example, expects that by 2015, serialization will be included on the item level, while China follows still another concept, including 1D linear codes as well as aggregation with shipping boxes.
“Our serialization service allows for unique identification of the unit level and transportation packaging,” says Thomas Otto, Vetter Managing Director. Therefore, we are providing a flexible response to the stricter demands of official agencies, while at the same time actively contributing to greater drug safety. Our customers benefit additionally from the fact that they can use the new service as a basis for their own track-and-trace program. Transparency in distribution prevents counterfeits, but it also promotes greater efficiency for processes along the supply chain.”