Sunday, 13 October 2019

FDA - Biological Product and HCT/P deviation reports annual summary for fiscal year 2018

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:

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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