Serialization in Pharmaceutical Production

Seri­al­iza­tion of phar­ma­ceu­ti­cals will become manda­to­ry in the Euro­pean Union. To pro­tect patients against forgery, med­i­cines must be seri­al­ized dur­ing pack­ag­ing and fit­ted with an anti-tam­per­ing device. Already back in 2009, the expe­ri­enced CDMO (Con­tract and Devel­op­ment Man­u­fac­tur­ing Orga­ni­za­tion) devel­oped sys­tems for seri­al­iza­tion and aggre­ga­tion and went live with sev­er­al pack­ag­ing lines in its facil­i­ty in Iller­tis­sen, Germany.
Today, R‑Pharm sup­ports man­u­fac­tur­ers, which are not ready for the upcom­ing require­ments, by pro­vid­ing pack­ag­ing capa­bil­i­ties includ­ing seri­al­iza­tion as a stan­dard ser­vice. In addi­tion, the com­pa­ny shares the rel­e­vant orga­ni­za­tion­al and tech­ni­cal exper­tise in a so-called “Track & Trace User Acad­e­my”, a col­lab­o­ra­tion with Met­tler Tole­do PCE found­ed in 2017. The sup­port by the com­pa­ny is reduc­ing the cus­tomers ramp-up phase to a minimum.
If a cus­tomer is not able to estab­lish the nec­es­sary equip­ment and pro­ce­dures in its own facil­i­ties in time, the com­pa­ny can bridge the gap guar­an­tee­ing to meet the deadline.
To avoid the invest­ment in the reg­u­la­to­ry-com­pli­ant seri­al­iza­tion and aggre­ga­tion sys­tems, cus­tomers may also decide to source out the pack­ag­ing to the firm completely.
The CDMO has many years of expe­ri­ence and is cer­ti­fied in over 150 mar­kets world­wide. Among them are all mar­kets, where reg­u­la­tions about seri­al­iza­tion of phar­ma­ceu­ti­cal prod­ucts are already effec­tive, like Korea, Chi­na, USA, EU and Sau­di Ara­bia. The inte­gra­tion in the firm´s sys­tems includ­ing the nec­es­sary IT solu­tions is smart and very con­ve­nient for new customers.
“Twelve months is an extreme­ly short time to set-up a prop­er sys­tem and the need­ed site orga­ni­za­tion for a seri­al­ized and aggre­gat­ed pro­duc­tion”, says Michael Unbe­haun, Man­ag­er Engi­neer­ing Site Projects: “If a man­u­fac­tur­er hasn´t start­ed yet with a sol­id imple­men­ta­tion project, it def­i­nite­ly is about time.”
To com­mis­sion a CDMO with seri­al­iza­tion and aggre­ga­tion is a pos­si­ble solu­tion, but even then, it is now time to take action, as capac­i­ties might be short soon.