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New requirements cut serialization deadline to three months
June 23, 2014
By: Kristin Brooks
Managing Editor, Contract Pharma
Aesica Pharmaceuticals S.r.l, the Italian division of Aesica, has launched a QAD integrated serialization system to comply with new requirements from China’s Food and Drug Administration (CFDA) at its site in Pianezza, which cut the serialization implementation deadline to three months from the previous 12 month timeline. In partnership with QAD, a provider of enterprise software solutions, Aesica implemented the serialization solution for two pharmaceutical products for the Chinese market. The new serialization solution allows Aesica to identify individual packaging down to the smallest sellable unit sizes and individual unit serial numbers as packages are bundled, boxed and placed on shipping pallets. Aesica Pianezza can track and trace each single pack of medication and report serial numbers to the required Government Agencies for a small number of products once produced and imported. Maurizio Beninati, IT manager Italy at Aesica Pharmaceuticals said, “Major changes are happening in product serialization 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.”
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