Implementation TQS for serialisation
In the future we will remain your reliable pharmaceutical contract partner. We’ll do this by investing in a Traceable Quality System (TQS) in order to comply with the new EU directive 2011/62/EU. Per February 2019 this directive comes into action.
Implementation Traceable Quality System (TQS) for serialisation
January 25, 2018
In the fight against counterfeit medicines, the European Union has published Directive 2011/62/EU. In short, this means that serialisation will become mandatory for prescription medicines by February 2019.
The basic requirement to counter counterfeiting is to ensure that each package is given a unique serial number combined with a product ID (GTIN/NTIN/PPN), a lot code and an expiration date. All this information must then be encrypted in a 2D data matrix code. Moreover, the serial number must not be easily reproducible. Furthermore, each package must be made tamper proof, ensuring the package has not yet been opened. The combination of all these measures is seen as the key to even safer medicines.
Building on the strict measures we already apply, we are investing in a Traceable Quality System (TQS) in order to comply with the new directive. The TQS enables serialisation of folding boxes by fully automatically applying and checking (scanning) the 2D data matrix code and applying tamper evident seals in one single effort.
Rest assured: we will remain your reliable pharmaceutical contract partner!