In its 2011 Guidance for Industry on Principles and Practice of Process Validation (1), FDA radically changed its interpretation of process validation. Validation now means “the collection and ...

Process validation is an extension of biologics development processes. When it comes to outsourcing process validation of biologics, Abel Hastings, director of process sciences at FUJIFILM Diosynth ...

The steps of a complex process can be displayed in sequence using a graphic referred to as a process flowchart. The graphic explains the way a process is or should be functioning, depending on the ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...