Biological Product Deviation Reports
FY 2001 Annual Summary
Table of Contents
- Executive Summary
- BPD Reports Submitted by Blood and Plasma Establishments
- BPD Reports Submitted by Manufacturers of Biological Products Other Than Blood and Blood Components (Non-Blood)
- Executive Summary
- 24,969 reports were from blood and plasma establishments
- the number of reporting blood establishments increased by 36%
- 398 reports were from non-blood manufacturers (allergenic, in-vitro diagnostic, therapeutic, derivative, or vaccine), which was an increase of 54%
- 1558 reports were submitted by unlicensed registered blood establishments and transfusion services, firms not required to report prior to May 7, 2001
- 1713 (6.8%) of the reports were sent to FDA District Offices for follow-up/evaluation as potential recall situations
- 1153 (4.5%) of the reports did not meet the threshold for reporting
- 1668 (6.7%) of the reports were submitted using the new electronic reporting website
- post-donation information (PDI) continues to be the most common reportable event for blood and plasma establishments (76.6% of reportable BPDs), with 89.9% of PDI known by the donor at the time of donation
- BPD Reports Submitted By Blood and Plasma Establishments
- BPD Reports Submitted By Manufacturers of Biological Products Other Than Blood and Blood Components (Non-Blood)
On November 7, 2000, FDA published a final that requires reporting of Biological Product Deviations (BPD), with an implementation date of May 7, 2001. BPD Reports must be submitted to the Center for Biologics Evaluation and Research (CBER) by licensed manufacturers of blood and blood components, including Source Plasma; unlicensed registered blood establishments; transfusion services who had control over the product when the deviation occurred (21 CFR 606.171), and by the non-blood manufacturer who holds the biological product license for and had control over the product when the deviation occurred (21 CFR 600.14). Detailed information concerning BPD reporting is available at www.fda.gov/cber/biodev/biodev.htm.
From October 1, 2000 through September 30, 2001 (Fiscal Year 2001 or FY01), CBER's Office of Compliance and Biologics Quality/Division of Inspections and Surveillance received 25,367 BPD reports:
BPD reports must now be submitted within 45 calendar days of the date of discovery of the reportable event. For FY 01, 75% of the reportable blood BPD reports and 56.6% of the reportable non-blood BPD reports were submitted within 45 days. FDA reviews reporting practices during establishment inspections and we continue to publicize reporting requirements through professional meetings and publications. We are exploring other outreach to industry, particularly unlicensed establishments including transfusion services, since those establishments are newly required to report.
FDA published two draft guidance documents in FY 01 to assist industry in determining what events are reportable as BPDs. We are carefully evaluating the comments received concerning these drafts and anticipate publication of final guidance in the near future.
Questions concerning this summary may be submitted to: Sharon O'Callaghan at ocallaghan@cber.fda.gov or Sue Cannon at cannon@cber.fda.gov or by telephone at 301-827-6220.
Questions may also be submitted to:
FDA/Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Division of Inspections and Surveillance (HFM-650)
1401 Rockville Pike, Suite 200 North
Rockville, Maryland 20852-1448
Attachment 1 - Number of Reportable BPDs by Blood and Plasma Establishment (PDF)
Attachment 2 - List of Reportable BPD Codes for Blood and Plasma (PDF)