Preparing Biological Product Deviation Reports: Suggestions for Manufacturers

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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Author(s): 
Barbara W. Unger, Don Hill Associates, Inc.
Journal: 
BioPharm International, October 2002.