The CDMO leads the market with a flexible, fast, single platform for regulatory compliance across multiple geographies
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
Speed is a key benefit of the modular platform. Catherine Kay, Operations Director commented: “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 right the way down to the smallest saleable ones
She continued: “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 minimized risk”.
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