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

October 15, 2002
Gail Sofer

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Joseph F. Noferi, Esq.

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Edward R. Arling

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Peter K. Watler, PhD

Peter K. Watler, PhD, is a principal consultant and chief technology officer at Hyde Engineering + Consulting, Inc.

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Anurag S. Rathore
Anurag S. Rathore

Anurag S. Rathore is a professor in the Department of Chemical Engineering at the Indian Institute of Technology Delhi and a member of BioPharm International's Editorial Advisory Board, Tel. +91.9650770650, asrathore@biotechcmz.com.

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Rhona O'Leary

BioPharm International, BioPharm International-10-01-2002, Volume 15, Issue 10

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.