Aesica 'ready to meet Chinese serialization requirements'

UK contract manufacturing organisation Aesica has started producing medicines that meet China's serialization requirements at its facility in Italy.

The CMO's site in Pianezza was asked by a customer last October to label two products in order to meet compliance with China's coding requirements - which came into effect on January 1 this year. Aesica got its system up and running in time with the help of software partner QAD.

The project had to run at breakneck speed because China shortened the timeframe for complying with its serialization plans, which are somewhat different to other initiatives ongoing in other territories around the world.

For instance, China is not using the GS1 numbering standards which underpin many of the other traceability systems in operation or being developed around the world, while it also uses linear barcodes rather than 2D datamatrix to avoid making the large number of laser scanners in the country obsolete.

It is also very different to other systems in play because the serial numbers for medicine packs are issued by the Chinese government to the manufacturer ahead of production, rather than generated by the drugmaker and reported to the authorities. The system also requires aggregation, so individual packs are linked to codes for shipping cases.

Aesica says ts system is able to code and 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.

At the moment China's requirements only apply to drugs on the country's Essential Drugs List (EDL), which was expanded in its 2012 edition to include many new products, rising from 307 to 520 medicines in total. By 2015 the requirements will apply to all prescription drugs sold in China.

"Major changes are happening in product serialization and tracking regulations across pharmaceutical markets worldwide and China is a prime example of this," commented Maurizio Beninati, IT manager at Italian subsidiary Aesica Pharmaceuticals S.r.I.

China's accelerated plans mean that it has now overtaken Europe and the US in the implementation of medicine serialisation, which is seen as an important barrier to the infiltration of counterfeit, diverted and stolen drugs into the supply chain.

Aesica's decision to invest in this area shows how quickly CMOs can respond to client requirements, despite concerns among some pharma industry players that the outsourcing sector is being slow in preparing for the various serialization requirements emerging around the globe.