|Articles|October 15, 2002

BioPharm International

  • BioPharm International-10-01-2002
  • Volume 15
  • 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.
To view a PDF of this article from the BioPharm International archives, click this link

Articles in this issue

over 23 years ago

FDA Launches Major CGMP Review

over 23 years ago

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

over 23 years ago

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

over 23 years ago

Biotech Will Recover!

over 23 years ago

GMPs and Pharmaceutical Labeling

over 23 years ago

Survival Guide to FDA Inspections: Part 2, Conducting the Audit ? Ready or Not, Here They Come

over 23 years ago

Revolutionizing Biologics Regulation

Newsletter

Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.

Subscribe Now!