FDA publishes draft of Biological Product Deviation Reports Summary

GMP News
25 June 2008
 

FDA publishes draft of Biological Product Deviation Reports Summary

  
The FDA published the draft of the Biological Product Deviation (BPD) Reports- Summary of the fiscal year 2007 (period From October 1, 2006 through September 30, 2007 (Fiscal Year 2007 or FY07).

This draft includes an Executive Summary and in the chapters 1 and 2 the submitted BPD Reports of blood and Plasma Establishments as well as the submitted BPD reports of manufacturers of biological products other than blood and blood components. Chapter 3 is about the HCT/P reports of manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P).They are all committed to submit this report to the Center for Biologics Evaluation and Research (CBER).

More details about the Draft you will find at http://www.fda.gov/cber/biodev/bpdrfy07.htm

More information about Biological Deviation Reports is available at
www.fda.gov/cber/biodev/biodev.htm.

Author:
Axel H. Schroeder
On behalf of the European Compliance Academy (ECA)
 

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