Updated on 17 May 2016
Aesica Pharmaceuticals, the global pharmaceutical contract development and manufacturing organisation (CDMO), provides a novel, modular based solution that provides pharmaceutical customers with a highly flexible, efficient and reliable technological resource that enables full and fast compliance with all the varying serialisation regulations across the globe - including China and Korea.
The modular technology and system has the distinct benefit of being the same for all countries, whilst enabling pharmaceutical customers to meet specific serialisation regulations that vary markedly across different nation states and regions. The highly flexible solution has the capability to maintain data in multiple formats bespoke to each country's individual regulatory rules. Consequently, customers are provided with a resource that ensures all serialisation requirements can be managed locally.
Aesica, which has long established expertise in the commercial production and packaging of pharmaceutical products at its European sites in Pianezza, Italy, Monheim, Germany and Queenborough, UK, is currently applying its novel solution to enable customers to meet the specific serialisation demands of China and South Korea. The implementation of serialisation services for the Chinese market, one of the world's most complex for serialisation regulations, took under six months for Aesica to complete. The company's serialisation module is also already on hand for customers that need to satisfy the demands of Brazil, the especially complex serialisation regulations of Turkey and Argentina and those faced by EU countries.
In the output phase, Aesica can create whatever files the customer requires including satisfying demand for a format that suits a specific country. Both the input and output of the data generated for serialisation and aggregation is completely customised.
The module provides full logistical flow and aggregation support - providing customers with the capability to seamlessly track and trace every single package of medication. The platform supports all levels of aggregation including units, shippers and pallets - with the capability to aggregate individual unit serial numbers as packages are bundled, boxed and placed on shipping pallets