Recipharm Ready for Serialisation and Delivers Complex Project for China

Recipharm has announced its readiness for serialisation and the successful completion of a complex serialisation project for China on behalf of one of its customers. A new regulation determining serialisation was introduced by the Chinese regulatory authority with strict importation deadlines set in place offering zero flexibility on full compliance.

Recipharm has developed a highly adaptable solution utilising a meticulous and methodical approach proven to ensure full and complete compliance. Fifty seven (57) serialised batches have already been supplied since February 2014.

The project, for a top ten pharmaceutical company was achieved in record time and a number of strategies to anticipate delays were adopted. Advanced planning ensured that all suppliers were thoroughly vetted and meticulously selected during the period between February and June 2013 with orders placed in early July of that year.

Integration was key, with Recipharm working closely with the pharmaceutical customer, forming project teams and  a joint steering committee. Costs were minimised and success ensured via the constant interchange of ideas and information. New technology was also introduced and applied to ensure each individual box has its own 1D barcode and unique serial number. 

Stéphane Guisado, General Manager at Recipharm Fontaine commented: “We are very pleased with the success of this China-focused serialisation project carried out for the pharma partner concerned. Traditionally, full compliance with China’s regulations, especially in the field of serialisation, has proved to be a major challenge for the pharma sector. There is no room for compromise when it comes to meeting regulatory deadlines. Moreover, the time-lines set by laws have to be met in full and on time and are often imposed with relatively short notice regarding implementation lead time.” He continued: "Consequently, Recipharm, as a forward looking CDMO, has now developed the skills and knowledge to provide a platform for delivering a serialisation solution for all markets.”