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 ...
The author describes various manufacturing processes and evaluates whether the guidance can be applied to each of them. In November 2008, the US Food and Drug Administration issued Draft Guidance for ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback