Aesica Pharmaceuticals, the Italian arm of Aesica Pharmaceuticals, has met the new serialization regulations for the Chinese markets by upgrading its system with QAD Enterprise Applications Enterprise Edition (QAD EE).
Being a contract development and manufacturing organization (CDMO), Aesica develops active pharmaceutical ingredients and formulate products.
The company came across an unexpected challenge when the deadline to meet Chinese serialization regulations was reduced from twelve months to three months.
Aesica had to meet these regulations keeping in mind of preventing drug counterfeiting, streamlining the recall process and minimizing financial loss.
Operating in highly regulated industry, the company sought for a solution to meet product serialization and tracking regulations to maintain customer safety. The QAD EE upgrade helped it to meet the challenge.
With the system implemented, the company can now identify each individual packaging unit down to the smallest sellable unit; aggregate individual unit serial numbers as packages are bundled, boxed and placed on shipping pallets; easily track and trace each single pack of medication.
The company could also report serial numbers to the required government agencies once products have been produced and imported.
Aesica Pharmaceuticals Italy IT manager Maurizio Beninati said QAD has been a great partner to help the company meet the unexpectedly accelerated deadline from China.
"We couldn't have conquered this challenge without their help and expertise," Beninati added.
