Vetter has announced the manufacture of the first commercial batches with single-use identification numbers in accordance with requirements from the South Korean Ministry of Food and Drug Safety (MFDS); Vetter’s solution identifies the drugs on the folding boxes via a 2D 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 the clear identification of products through serialisation. They are demanding that the smallest packaging units be marked with a single-use identification number. South Korea is among those countries requiring serialisation with the aim of protecting against counterfeiting, as well as ensuring a more secure supply chain.
Following the introduction of a comprehensive serialisation service last year, Vetter has now implemented product serialisation for secondary packaging for one of the world’s leading pharmaceutical companies.
‘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 serialisation service, our partners 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 pharmaceutical 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 serialisation on the folding package. China, however, has legislated the use of 1D 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 serialisation service includes a range of formats for serial numbers and different code systems, such as 2D data matrix codes, interfaces and reports, as well as various aggregation depths. Pharmaceutical and biotech companies can use Vetter’s individually customisable solutions as basis for their own track-and-trace programmes to optimise their supply chain.
