Qualifications & Validation

GMP Annex 15 states that: “The manufacturer of process equipment should control the critical aspects of the operations it carries out by means of a qualification and validation programme throughout the life cycle and the process.”
We apply the qualification process in accordance with the rules of Good Manufacturing Practice (GMP).
GMP Annex 15 also states that: “All planned changes to facilities, equipment, utilities and processes which may affect product quality should be formally documented, and the impact on the validation status or control strategy should be assessed.” We therefore put in place and supply detailed, complete and compliant documentation for every qualification/validation service performed on your equipment and/or processes.

OUR STRENGTHS:
> REUSABLE FAT/SAT: Compliant FAT tests are carried over to the SAT once the equipment has been installed on site.
> SAT / IQ+OQ CARRY-OVER: Compliant SAT tests are also carried over to the IQ/OQ qualification services before the machine is started up.
> TIME SAVING: Reduced downtime for the process equipment and therefore lower non-production costs.

To find out more, download the data sheet below or request a quotation.

Together, let us find the solutions that suit your production processes.
The simplest way is to have a sales engineer visit your site so that we can familiarise ourselves with your challenges. At STERIGENE, we are confident we can help you choose and implement the solutions that will secure, future-proof and sustain your production area.