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The Czech Republic drug manufacturer was cited for data integrity and quality issues.
FDA has cited another company for data integrity violations. A warning letter, dated Oct. 18, 2016, was sent to Interpharm Praha A.S of the Czech Republic and detailed a number of current good manufacturing practice (CGMP) violations in the manufacture of APIs and finished drug products found during an October 2015 inspection of the company’s Modrany facility.
Data integrity violations found during the inspection included a failure to prevent unauthorized access or changes to data. According to the warning letter, the company’s automated system made it possible for analysts to delete or alter test results, and therefore, the quality unit did not have complete and accurate quality information.
FDA found the company’s response to the violation inadequate, stating, “According to your response, you restricted access and permissions in the Empower 2 automated data system. However, your response does not demonstrate how the specific controls you have implemented prevent deletion or alteration of data, nor have you shown how you will ensure that these permissions are documented, implemented, and followed. Finally, you have not shown how these controls ensure that records relied upon for batch release and other quality review decisions are complete and accurate.”
The agency advised the company to perform a “comprehensive investigation” into the extent of the data integrity issues, provide a risk assessment on the potential effect of the violations on the quality of the company’s product, and develop a management strategy that includes a global corrective action and preventive action plan.
A failure to establish laboratory controls was also found by FDA. “Your laboratory procedures allowed analysts to modify and delete chromatographic results without adequate justification, and to use manual integration in uncontrolled circumstances,” the warning letter stated. FDA asked the company to “describe all steps you will take to ensure that appropriate laboratory controls have been implemented to support product quality review and batch release decisions. Include the controls you will implement for the modification, deletion, and manual integration of chromatographic test results.”