Preparing Biological Product Deviation Reports: Suggestions for Manufacturers

Unger,Barbara;

Publication

Article

October 15, 2002

BioPharm International

BioPharm International-10-01-2002

Volume15

Issue 10

Preparing Biological Product Deviation Reports: Suggestions for Manufacturers

Author(s):

Barbara Unger

by Barbara W. Unger, Don Hill Associates, Inc. Rarely do manufacturers of biologics need to prepare a Biological Product Deviation Report (formerly called and Error and Accident Report); in fact, few manufacturers ever have to complete one. But all manufacturers need to have an SOP describing how to complete this report, in case it becomes necessary.

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

Biotech Will Recover!

Preparing Biological Product Deviation Reports: Suggestions for Manufacturers

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