Only those who have an in-depth, technical understanding of the equipment and understand the process requirements can profitably and reliably qualify a plant for the subsequent user. Our qualification staff can always draw on our internal network of GMP specialists This enables them to make the best decision for you and your product, even in difficult situations, and to provide you with advice.
In order to meet your individual requirements, we offer you a qualification system specially developed by us. This is based on the current ISPE Guidelines and takes the requirements of Annex 15, FDA Guidance for Industry into account: Process Validation and ICH Q9.
Of course, this system can be adapted to your individual requirements and wishes and thus promises individually suitable solutions. Qualification is integrated into all planning and execution phases as a kind of project controlling.