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Article: 47% of biologic 483s cite process faults; validation in retro urged.
- Article from:
- Validation Times
- Article date:
- February 1, 2001
- Author:
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SAN DIEGO With 47% of all 483s involving audits of biological therapeutics firms citing process errors, a former Center for Biologics official said companies need to do retrospective validation, and concurrent validation, if necessary, but consult with FDA.
Dr. Edward Fitzgerald, Ph.D., Fitzgerald Consulting, Rockville, MD, told an International Business Communications (IBC) conference Jan. 29, there also is room for concurrent validation.
He said most of these 483 citations concern traditional biologicals, including vaccines, tuberculin and allergenic extracts. Fitzgerald noted most of these are being made in old facilities without proper validation ...