Flexible, fast, single platform for regulatory compliance across the globe
UK-based contract development and pharmaceutical organisation (CDMO) Aesica Pharmaceuticals is offering a novel, module based serialisation solution that provides pharmaceutical firms with a flexible, efficient and reliable service that enables full and fast compliance with all the varying serialisation regulations across the globe.
The 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 European sites in Pianezza, Italy, Monheim, Germany and Queenborough, UK, is currently applying its solution to enable customers to meet the specific serialisation demands of China and South Korea. The implementation for the Chinese market, one of the world’s most complex for serialisation regulations, took under six months to complete.
The serialisation module is also already under development for customers that need to satisfy the demands of Brazil, 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 medication package. The technology 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.
Catherine Kay, Aesica's Operations Director, said: 'A key advantage of our solution is both the flexibility and the pace with which it can respond to changing customer needs. After discussing and analysing the precise customer requirement, Aesica can respond by carrying out and initiating its serialisation services in very rapid time.'
Aesica’s packaging lines are flexible enough to support multiple serialisation and coding requirements. The CDMO can receive the information, including purchase orders and pre assigned serial codes, and has the capability to upload the data into its ERP application. Aesica can identify each individual packaging unit.
Kay added: 'Specialist technical knowledge has become essential to servicing the needs of customers in serialisation. This includes possessing familiarity with the critical interfaces between the various scientific and functional aspects and knowing how to balance them to reach the optimal solution, accommodating relevant regulatory requirements and advanced market technology demands. Ultimately, this results in increased control, the highest levels of efficiency and minimised risk.'