11/12 October 2022
Quality and Safety of products by biological origin had an increasing importance in the near past. This can also be seen in the increasing number of guidance documents referring to this topic, like the guidances
Therefore, in accordance with the current requirements in 21CFR, the manufacturers had to submit reports about deviations or unexpected events relating to safety, purity, or potency of a distributed product occuring under their responsibility. This includes the following establishments:
Further, if is related to a Core Current Good Tissue Practice requirement [21 CFR 1271.150(b)] and related to the prevention of communicable disease transmission or HCT/P contamination, it also affects
The FDA now published an annual summary report which provides an overview of the reports they received during the fiscal year, including detailed information regarding the number and types of deviation reports received. The FDA provides combined data received over the last three fiscal years in an effort to compare data and highlight changes.
In the time frame of FY 2016, the FDA entered more than 51.229 reports into their Biological Product Deviation (BPD) database. This was an increase of 10% (or 4.642 reports) compared to FY2015. For blood and source plasma establishments, it was an increase of 4.546 reports, for manufacturers of other licensed biological products an increase of 93 reports. In detail that was spread as follows:
The total number of reporting establishments increased from 1.907 to 1.950. To learn more about the developments and see the tables with the comparison of the last three years, please see the complete "Biological Product and HCT/P Deviation Reports".