For Blood / Biologics

Majority of Biological Product Deviation Reports Related to Post-Donation Information


FDA Issues Annual Summary of Deviation Reports



The FDA received 38,618 biological product deviation (BDP) reports for fiscal year 2006, 72 percent of which stemmed from donor-suitability problems that were not detected during initial donor interview.

Of the total BDP reports, 27,427 were under the category of ?post-donation information? (PDI), which means donor-suitability problems were discovered only during subsequent interviews with donors, according to a report released by the FDA's Center for Biologics Evaluation and Research (CBER) in March. Forty-five percent of PDI reports were related to travels that were not disclosed during initial interviews with donors. Recent travel to places considered high risk for certain diseases may disqualify donors under stringent FDA screening rules.

?In 90 percent of the PDI reports the donor was aware of the information, but the donor screening process failed to elicit the information. It is unclear why blood establishments are unable to elicit information during the first donor interview, but successfully elicit the information during a subsequent interview,? according to the CBER report.

Some 4,134 reports, or 10.8 percent of deviation reports, fell under the ?quality control and distribution? category. This refers to products that did not meet specifications, such as when a product has unacceptable, undocumented, or incomplete product QC.

The number of deviation reports for fiscal 2006 was about the same as the total number for fiscal year 2005 (38,757). The number of reporting establishments increased by 4 percent (1,409 establishments in FY05 and 1,481 establishments in FY06). There were 80 additional HCT/P establishments reporting in FY06 that did not submit reports in FY05.

The FDA requires the reporting of any biological product deviations, which refer to events that may affect the safety, purity, or potency of a distributed biological product, and which may represent an unexpected deviation from current Good Manufacturing Practice (cGMP), applicable regulations, applicable standards, or established specifications.


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FDA Link

  • Biological Product and HCT/P Deviation Reports for FY 2006
    Link

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