Risk Assessment based approach to support the qualification of equipment: a case study application on a mammalian cell bioreaction system

Introduction: The equipment qualification within the pharmaceutical industry, besides being mandatory, is indispensable to verify that any equipment was designed, installed, and operates to perform the expected function. However, high technological complexity of innovative and customized systems makes it difficult to execute this task, requiring high human and financial resources. To face this situation, a risk analysis based approach has been used to simplify the qualification tests in key elements and critical functions within the system, resulting in the optimization of resources and reduction of qualification time, which in some cases may take years.