Back to overview

Our sys­tems are qual­i­fied and our pro­cesses and pack­aging solu­tions are val­id­ated. We are com­mit­ted to com­ply­ing with Good Man­u­fac­tur­ing Prac­tice (GMP) stand­ards for early pack­aging, which form the basis for high-qual­ity pro­duc­tion pro­cesses in the phar­ma­ceut­ic­al and med­ic­al tech­no­logy sectors.

We sub­ject our qual­i­fied facil­it­ies and envir­on­ment­al con­di­tions as well as all pro­duc­tion pro­cesses to a con­tinu­ous valid­ity check with the fol­low­ing GMP standards:

Design Qual­i­fic­a­tion (DQ) 
We ensure that the plan­ning and design of our plants and sys­tems meet the spe­cified require­ments right from the start. This is the first step in guar­an­tee­ing the qual­ity and func­tion­al­ity of our solutions.

Install­a­tion Qual­i­fic­a­tion (IQ)
Dur­ing install­a­tion qual­i­fic­a­tion, we check that our sys­tems and devices are cor­rectly installed and con­figured. This check ensures that all com­pon­ents func­tion in accord­ance with the man­u­fac­turer­’s spe­cific­a­tions and our own high standards.

Design of Exper­i­ment (DOE)
With this approach, we sys­tem­at­ic­ally exam­ine the influ­ence of vari­ous factors on our pro­cesses. This helps us to identi­fy optim­iz­a­tion oppor­tun­it­ies and increase the effi­ciency of our processes.

Oper­a­tion­al Qual­i­fic­a­tion (OQ)
Oper­a­tion­al qual­i­fic­a­tion is a cru­cial step in which we test the per­form­ance of our sys­tems under defined con­di­tions. We ensure that our sys­tems func­tion con­sist­ently and reli­ably under all inten­ded oper­at­ing conditions.

Per­form­ance Qual­i­fic­a­tion (PQ)
In this phase, we val­id­ate the per­form­ance of our pro­cesses in reg­u­lar oper­a­tion. We con­firm that our sys­tems work con­sist­ently and accord­ing to the defined spe­cific­a­tions over an exten­ded peri­od of time.

Through these com­pre­hens­ive GMP-based qual­i­fic­a­tions, we ensure that our sys­tems and pro­cesses not only meet the highest stand­ards, but are also reg­u­larly reviewed and updated. This con­tinu­ous mon­it­or­ing and improve­ment is part of our com­mit­ment to provid­ing our cus­tom­ers with the highest qual­ity and safety in med­ic­al device and phar­ma­ceut­ic­al packaging.