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Warning Letter issued to BBT Biotech, Germany by USFDA on account of Data Integrity Issues

The USFDA has issued a warning letter to BBT Biotech; Germany on account of GMP violations. The company needs to respond to the letter with measures taken to remedify the deviations / violations within 15 working days of receipt of the letter.

During the inspection, the inspectors observed specific deviations including, but not limited to, the following.

• Failure to follow a documented, on-going stability testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates. • Failure to establish and follow a change management system evaluating all changes that could affect the production and control of company’s API, and failure to evaluate the potential effect changes that may have on the quality of API. • Failure to adequately investigate out-of-specification (OOS) results. • Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and to provide adequate controls to prevent omission of data.

The company committed to hire an external expert to install audit trails and take further measures to ensure that data cannot be deleted. According to the FDA, this commitment was inadequate. The FDA expected the company to demonstrate that through the measures taken all data collected as part of a cGMP report before releasing APIs can be retained and evaluated. The FDA now further expects the company to investigate the retention and review of the cGMP data focussing on laboratory raw data and a plan from the company on the control of retaining and reviewing data and the implementation of adequate access controls and audit trail capabilities.


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