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)