Recipharm Delivers Complex Serialization Project for China
Recipharm, the leading contract development and manufacturing organization (CDMO), announced the completion of a complex serialization project for China on behalf of one of its customers. A new regulation determining serialization 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 utilizing a meticulous and methodical approach proven to ensure full and complete compliance. Fifty seven serialized 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 minimized 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 serialization project carried out for the pharma partner concerned. Traditionally, full compliance with China's regulations, especially in the field of serialization, 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 serialization solution for all markets."