The
U.S. FDA requires reporting of certain deviations and unexpected events in
manufacturing in accordance with 21 CFR 600.14, 606.171 or 1271.350(b). The following manufacturers, who had control
over the product when an event associated with manufacturing (deviation or
unexpected event) occurred, are required to submit Biological Product Deviation
(BPD) reports to the Center for Biologics Evaluation and Research (CBER), if
the safety, purity, or potency of a distributed product may be affected.
This
annual summary report provides an overview of the reports received by FDA during
the fiscal year, including detailed information regarding the number and types
of deviation reports received. Each firm responsible for reporting biological
product and HCT/P deviations needs to use this information in evaluating their
own deviation management program.
The
current review can be found here: https://www.fda.gov/media/129692/download
Posted by Dr. Tim Sandle,
Pharmaceutical Microbiology
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