Preparing Biological Product Deviation Reports: Suggestions for Manufacturers

Published on: 
BioPharm International, BioPharm International-10-01-2002, Volume 15, Issue 10

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.