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

Sofer,Gail;Noferi,Joseph;Arling,Edward;Watler,Peter;Rathore,Anurag;Rhona O'Leary;

Publication

Article

October 15, 2002

BioPharm International

BioPharm International-10-01-2002

Volume15

Issue 10

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

Author(s):

Gail Sofer,Joseph F. Noferi, Esq.

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.

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FDA Launches Major CGMP Review

Virus Inactivation in the 1990s ? and into the 21st Century: Part 3b, Plasma and Plasma Products (Treatments Other than Heat or Solvent/Detergent)

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

Biotech Will Recover!

Preparing Biological Product Deviation Reports: Suggestions for Manufacturers

GMPs and Pharmaceutical Labeling

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

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