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

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.

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Author(s):
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
Journal:
BioPharm International, October 2002
Copyright:
BioPharm International