Qualification is a constant topic in the GMP-regulated industry, because the tasks are manifold, the "how" is not explicit described, and the path to the goal can be divided into almost any number of individual steps. All of this makes qualification a task that is time-, cost- and personnel-intensive for many companies.
It is possible to save resources and still comply with the regulations correctly!
One approach to this can be seen in standard devices. These are devices that are widely used in the market, are manufactured according to standardized construction plans with only little influence on the design, and for which there are only manageable risks. Here, there is an opportunity to significantly simplify qualification with well-used standardization.
Inspired by practical experience and verified in numerous projects, gempex has developed a concept for the resource-saving and inspection-safe qualification of standard equipment.
This unified approach is the subject of a presentation gempex will give at the 25th Swiss Cleanroon Community Event, 06 November 2023 from 15:30, in Pratteln:
Qualification of Standard Equipment - Exploiting Potential, Saving Resources
Dominik Unglaub, Consultant gempex GmbH, Sisseln
The basic approach is explained and an insight is given into the exemplary structure and content of the necessary qualification documentation.
At the gempex booth at the accompanying trade exhibition, there will be the opportunity to delve deeper into the topic. Ralf Gengenbach, Managing Director of gempex, and Dominik Unglaub, Consultant, will be available to answer questions and share experiences.
Questions on the topic can also be addressed via contact@gempex.com.