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.