Anyone who deals with the topic of GMP today must inevitably also deal with the topic of "qualification".In doing so, one quickly realizes that the subject is a time-consuming, costly and personnel-intensive matter. The person is also confronted with all the difficulties of a precise definition and interpretation and with the question: "How do I carry out the qualification correctly and in a resource-optimized manner?"
In simple terms, the term qualification refers to proof that technical systems are suitable for the intended purpose. However, people often overshoot the mark.Tests are repeated, tests are carried out several times and pointless amounts of paper are generated. The tests that are carried out under the heading of qualification are usually already an integral part of the usual technical tests and the system is checked again technically. This procedure not only consumes resources unnecessarily, but also runs counter to the modern approach of integrated qualification.
Today, it is more important than ever to pursue a modern approach in which qualification is approached in a targeted and resource-saving manner. One possible approach is the categorization of devices in order to carry out the qualification effort according to the situation.