Counterfeit drug revenues are estimated to be in the region of $75 Billion in 2010 and are projected to grow at 13% annually. The World Health Organisation states that it is impossible to quantify the size of the problem but that it may be as much as 10% of the global market. As the Life Sciences industry and associated regulatory bodies look to tackle re-imbursement fraud and to address the serious concerns of counterfeit medications, it is imperative that organisations can adapt existing production systems and processes quickly and efficiently to enable them to comply with the raft of new directives that will be coming into force in the near future.
What is pharmaceutical Serialization labeling?
Many different solutions are being trialled across the world, all focused on reducing the impact of fraud within the pharmaceutical industry. Most involve the application of a unique random identifier that can be verified at – various parts of the supply chain – point of issue to the end user.
Systems need to allow these unique numbers to be coded to the appropriate standard (GS1, RFID, DataMatrix) and then to be applied to the product quickly and efficiently, using existing technology where appropriate.
Label Printing
During production, when label printing or marking directly onto products, all print actions need to be automatically recorded including details such as who, what (batch, lot, GTIN and serialisation code), when and why are all written to a secure location on the server.
The security of both the client and the server is ensured by a combination of the operating system and application software. The security is well proven and documented as part of the system validation support services.
How Prisym ID can help?
Prisym Medica allows these unique random identifier numbers to be coded to the appropriate standard (GS1, RFID, DataMatrix) and then to be applied to the product quickly and efficiently, using existing technology where appropriate.
PRISYM Medica is specifically developed to meet the FDA’s current requirements and is fully supported by our own software life-cycle documentation based on the GAMP ‘V’ Model.
Working with Oracle Pedigree and serialization labeling Manager which can provide very high volumes of unique, secured and ‘intelligent’ serial numbers, PRISYM Medica for Oracle can ensure that your business can meet the requirements for serialized products now and in the future.
