New system was implemented within three months
Aesica Pharmaceuticals, the Italian division of global pharmaceutical CDMO Aesica, has launched a QAD integrated serialisation system at its site in Pianezza to meet the shorter deadline imposed by the Chinese Food and Drug Administration (CFDA). The new requirements are designed to maintain customer safety, while fighting drug counterfeiting, streamlining the recall process and minimising financial loss.
The CFDA has cut the serialisation implementation deadline drastically to just three months from its original 12 month timeline. In partnership with QAD - a leading provider of enterprise software solutions - Aesica was able to implement a new solution that assured serialisation compliance for two pharmaceutical products for the Chinese market.
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 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.
'Major changes are happening in product serialisation and tracking regulations across pharmaceutical markets worldwide and China is a prime example of this,' said Maurizio Beninati, IT Manager Italy at Aesica Pharmaceuticals .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.'
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.'