Warning Letter: Analyst manipulated and deleted audit trails (ucm546319)

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Ofni Systems

Your quality control laboratory disregarded multiple out-of-specification (OOS) impurity results without justification. For example, on September 22, 2015, you encountered an OOS unknown impurity peak during high performance liquid chromatography (HPLC) testing of [redacted] 36-month stability batch [redacted].  You terminated the analysis.  Testing of a new sample also showed the OOS impurity peak.  The chromatogram was then manually rescaled, which hid the presence of this peak.  Your laboratory set the integration parameters to omit this peak from integration. Because the peak was omitted, the quality unit was not provided with full information to evaluate whether the stability batch, and potentially other marketed batches, continued to meet quality standards.

In addition, your audit trail showed that from July 1 to 2, 2015, you performed seven sample injections of [redacted] 60-month stability batch [redacted] to test for impurities using HPLC.  You permanently deleted the first five sample injections. You then renamed the last two injections and reported that they met specifications.  Your quality unit failed to identify and address these serious data manipulations…

Failure to prevent unauthorized access or changes to data, and failure to provide adequate controls to prevent omission of data.

Our investigator observed that your laboratory systems lacked controls to prevent your staff from altering or deleting electronic data. Analysts manipulated and deleted audit trails.  You lacked adequate controls for all HPLC, gas chromatography, and ultra-violet systems.

For example, an analyst deleted audit trails in your gas chromatography equipment #YQ-07-10 from September 15, 2015, through April 24, 2016, and permanently deleted audit trails from November 6 to 13, 2015.  In addition, our investigator observed that your quality control manager and quality control deputy manager had full administrative rights on all of your computerized systems, which allows them to manipulate data and turn off audit trails.

View the original warning letter.


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