Rhona O'Leary

Genentech, Inc.


Process Validation: How Much to Do and When to Do It

by Anurag S. Rathore, Joseph F. Noferi, and Edward R. Arling from Pharmacia Corporation, and Gail Sofer, Bioreliance; Peter Watler, Amgen, Inc.; and Rhona O'Leary, Genentech, Inc. The trick to process validation, these industry experts argue, is to understand that it is a process that stretches through the whole product life cycle. Some secrets of success: Take a team approach; focus on the timing of the various stages of validation; avoid some common mistakes; and build your documentation as you go.