Our equip­ment is qual­i­fied, and our pro­cesses and pack­aging solu­tions are val­id­ated. At Früh Ver­pack­ung­s­tech­nik AG, we are com­mit­ted to com­ply­ing with Good Man­u­fac­tur­ing Prac­tice (GMP) stand­ards, which form the basis for high-qual­ity pro­duc­tion pro­cesses in the phar­ma­ceut­ic­al and med­ic­al device industries.

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) 
In doing so, we ensure that the plan­ning and design of our facil­it­ies meet the defined require­ments from the out­set. This is the first step in guar­an­tee­ing the qual­ity and func­tion­al­ity of our solutions.

Install­a­tion qual­i­fic­a­tion (IQ)
Dur­ing install­a­tion qual­i­fic­a­tion, we check that our facil­it­ies 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 identi­fy optim­iz­a­tion oppor­tun­it­ies and increase the effi­ciency of our processes.

Oper­a­tion­al qual­i­fic­a­tion (OQ)
Oper­a­tion­al qual­i­fic­a­tion is a crit­ic­al step in which we test the per­form­ance of our sys­tems under defined con­di­tions. We ensure that our facil­it­ies oper­ate 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 will oper­ate con­sist­ently and in accord­ance with the spe­cified spe­cific­a­tions over a longer peri­od of time.

Through these com­pre­hens­ive qual­i­fic­a­tions based on GMP, we ensure that our facil­it­ies and pro­cesses not only meet the highest stand­ards but are also reg­u­larly checked 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.

We sub­ject our qual­i­fied sys­tems and envir­on­ment­al con­di­tions as well as all pro­duc­tion pro­cesses to con­tinu­ous val­id­a­tion checks.