Pharma/Diagnostics

Absolutely precise ambient conditions, qualified utilities and clean, sterile areas in a valid environment are basic requirements in cutting-etch production of pharmaceutical and diagnostic products or laboratories. Because of our expertise in pharmaceutical industries we are able to handle technological projects in the fields of life science, diagnostics, biotechnology and the manufacture of pharmaceutical products in compliance with complex GMP/FDA qualification processes. Amperox prepares an individual validation plan for its customers, we analyze internal processes, evaluate utilization respective facility requirements and adapt all conditions to the production process. During project implementation we create all necessary obligation documents and functional specifications as well as validation and qualification plans, supervise and monitore their execution in accordance with GMP/FDA requirements and hand over a qualification report until commissioning.