Aesica Upgrades Serilization CapabilitiesBy
Aesica Pharmaceuticals S.r.l, the Italian division of Aesica, a contract development and manufacturing organization, has launched a QAD-integrated serialization 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 cut the serialization implementation deadline to three months from its original 12 month timeline.
In partnership with QAD, a provider of enterprise software solutions, Aesica was able to implement a new solution that assured serialization compliance for two pharmaceutical products for the Chinese market. The new requirements are designed to maintain customer safety while addressing drug counterfeiting, streamlining the recall process, and mitigating financial loss. Primarily it involved upgrading and utilizing a newly created serialization module developed in QAD Enterprise Applications. This module, which was specifically developed to meet the new serialization regulations, allows Aesica Pharmaceuticals S.r.I. to identify individual packaging to small, sellable unit sizes and aggregate individual unit serial numbers as packages are bundled, boxed, and placed on shipping pallets. This allows the company to 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 serialization module to fruition. In addition, Aesica developed a new Enterprise Financials module serving as a \all-in-one solution for multiple financial requirements and procedures. This module reduces the number of applications in use, achieving the goal of covering all business processes in one complete enterprise resource planning solution.