SOUTH KOREA – A top-ten pharmaceutical company has been able to successfully implement product serialization for secondary packaging to comply with regulatory requirements in South Korea.
Vetter – a German fill & finish contract manufacturer of aseptically prefilled syringe systems, cartridges, and vials – manufactured the first commercial batches with single-use identification numbers for secondary packaging for one of the world's leading pharmaceutical companies.
In accordance with the requirements from the South Korean Ministry of Food and Drug Safety (MFDS) Vetter's solution identifies the drugs on the folding boxes via a 2-D data matrix code with a serial number, GTIN, expiry date, and batch number.
As the number of counterfeit drugs continues to grow, regulatory authorities around the world are increasingly relying on clear identification of products through serialization, explained Vetter, with countries demanding that the smallest packaging unit be marked with a single-use identification number. South Korea is among those countries requiring serialization with an aim towards protecting against counterfeiting, as well as a more secure supply chain.
"Together with our customer, we prepared for these requirements very early on," says Thomas Otto, managing director at Vetter. "We have been active in filling and final packaging for the company for years. Thanks to our serialization service, our partner can now meet the regulatory requirements for South Korea.
“We are, however, also aware of the fact that regulatory requirements differ from one country to the next. Therefore, we offer pharma and biotech companies a wide range of options that will give them flexibility when reacting to different regulatory standards."
Presently, South Korea has only asked for serialization on the folding package. China, however, has legislated use of 1-D linear codes including aggregation with the shipping box. As such, Vetter provides a broad variety of services in secondary packaging, primary packaging and final assembly that give its customers a great deal of flexibility to accommodate various regulatory or market needs.
The company's comprehensive serialization service includes a range of formats for serial numbers, different code systems; such as a 2-D data matrix codes, interfaces and reports, as well as various aggregation depths. Pharmaceutical and biotech companies can use Vetter's individually customizable solutions as basis for their own track-and-trace programs to optimize their supply chain.
Vetter completes first commercial serialization project for South Korea