Uptick in Data Integrity Problems Leads FDA to Better Define Types and Red Flags

An uptick in the number of data integrity problems that FDA is finding at manufacturing and testing facilities is prompting the drug compliance office to better define the forms in which the integrity problems can appear and the red flags that will trigger more intensive investigations.

At the annual University of Georgia/FDA International GMP conference in Athens, GA in March, CDER Office of Compliance Senior Policy Advisor Karen Takahashi provided an update on her office’s current thinking on data integrity issues and what FDA is looking for and finding during its inspections.

Takahashi covered: ● the red flags FDA looks for that may indicate the potential for data integrity problems ● what triggers the agency’s application integrity policy (AIP) ● what impact data integrity problems have on firms ● how firms can resolve the problems and rebuild trust with the agency, and ● examples of data integrity issues the agency is finding during inspections.

Pointing to the uptick in the findings, she commented that her office doesn’t know “if that is because there are more data integrity problems or if we are getting better at finding them – or a little bit of both.”

She noted that the agency has recently been using consent decrees to address the application-related integrity problems it has uncovered when the evidence warrants a strong enforcement response (see IPQ “The News in Depth” January 30, 2012 and March 8, 2011). The issues have also been appearing in warning letters with accompanying import alerts on foreign company production to mark further FDA’s view of the seriousness of the findings (see IPQ “The News in Depth” July 11, 2011, June 16, 2011, and June 13, 2011).

“Data integrity problems break trust,” Takahashi stressed. “In the time between inspections, we trust you to do the right thing.  And if we finish an inspection and that trust has been broken, then we need to go through a few exercises to build that trust before we can go forward and trust you until the next inspection.”

Data integrity issues that the agency has been finding include: ● not recording activities contemporaneously ● backdating ● fabricating data ● copying existing data as new data ● re-running samples ● discarding data ● releasing failing product ● testing into compliance, and ● not saving electronic or hard copy data.

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