Aesica Pharmaceuticals SrI Collaborates with QAD to Meet China’s FDA’s Shortened Serialisation Deadline

Aesica Pharmaceuticals Srl, the Italian division of Aesica, the global pharmaceutical contract development and manufacturing organisation (CDMO), has launched a QAD integrated serialisation system to comply with change from China’s Food and Drug Administration (CFDA) at its site in Pianezza. The new requirements brought forward by CFDA drastically cut the serialisation implementation deadline to just 3 months from its original 12-month timeline. 

In partnership with QAD, Aesica was able to implement a new solution that assured serialisation compliance for two pharmaceutical products for the Chinese market. The company site demonstrated the ability to quickly react to unexpected changes within this regional regulatory landscape. 

The new requirements are designed to maintain customer safety, whilst fighting drug counterfeiting, streamlining the recall process and minimising financial loss. Primarily it involved upgrading and utilising a newly created serialisation module developed in QAD Enterprise Applications. This module, which was specifically developed to meet the new serialisation regulations, allows Aesica Pharmaceuticals SrI to identify individual packaging down to the smallest sellable unit sizes and aggregate individual unit serial numbers as packages are bundled, boxed and placed on shipping pallets. Aesica Pianezza can seamlessly track and trace each single pack of medication and report serial numbers to the required Government Agencies for a small number of products once they have been produced and imported.

QAD’s research and development team worked directly with Aesica’s Information Technology group to bring the new serialisation module to fruition. In addition, Aesica has developed a new Enterprise Financials module serving as a complete all-in-one solution for multiple financial requirements and procedures. This module significantly reduces the number of applications in use, achieving the goal of covering all business processes in one complete Enterprise Resource Planning (ERP) solution.

Maurizio Beninati, IT Manager Italy at Aesica Pharmaceuticals SrI, commented: “Major changes are happening in product serialisation and tracking regulations across pharmaceutical markets worldwide and China is a prime example of this. The ability to respond swiftly to adjust practices and processes to meet these challenges head on is pivotal to success in this fiercely competitive environment. QAD has proven to be a great strategic partner in the rush to meet such a hugely accelerated deadline from the CFDA. By combining our respective skills and expertise, we conquered this challenge in full.”

Bhavesh Kotecha, Corporate Services Director at Aesica, added: “At Pianezza we work with pharmaceutical companies to manufacture products for the Chinese market, and we are pleased to have worked closely with QAD to ensure a secure product line for the two pharmaceutical products. The strategic decision to keep and upgrade QAD as the ERP system at our Italian facility has proved to have been a highly successful choice. The solution is now in place to meet the requirements and regulations of the Chinese pharmaceutical market, establishing the scale of our ability to react and adapt quickly to challenging situations.”