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Multiple data-integrity violations results in FDA warning letter for Mumbai, India-based Ipca Laboratories.
Ipca Laboratories, a Mumbai, India-based drug manufacturer, has received a lengthy warning letter from FDA for good manufacturing practice (GMP) violations identified during inspections in 2014 at three facilities. The company’s Ratlam facility was cited for “significant deviations” for API manufacturing and the Pithampur and Piparia Silvassa facilities for violations of current GMPs for finished pharmaceuticals.
The Ratlam facility was cited for failure to have sufficient computer system controls to prevent unauthorized access or changes to data. FDA investigators noted a lack of basic laboratory controls to prevent changes to electronically stored data; and use of incomplete records to evaluate the quality of drugs and to determine whether the drugs conformed with established specifications and standards.
FDA reports that Ipca “routinely re-tested samples without justification, and deleted analytical data. We observed systemic data manipulation across your facility, including actions taken by multiple analysts, on multiple pieces of testing equipment, and for multiple drugs.”
FDA further noted that laboratory analysts had administrator access to chromatography systems and used the access to to manipulate raw data and test results. FDA found that the computerized chromatographic instrumentation system did not prevent analysts from manipulating processing parameters in order to obtain passing results, and the computerized systems lacked controls to prevent the back-dating of test data.
FDA noted that the firm’s quality unit was aware of the lack of controls in the computerized systems to prevent the manipulation and deletion of quality-related data, but “senior management failed to take sufficient corrective action and prevent the recurrence of these problems,” the letter reported.
The agency also noted that the firm lacked a robust corrective action and preventive action (CAPA) program; failed to follow and document laboratory controls at the time of performance; and failed to document and explain any departures from laboratory procedures.
Finished drug manufacturing violations
FDA noted that the company failed to ensure that laboratory records at the Pithampur drug product manufacturing facility include complete data derived from all tests necessary to assure compliance with established specifications and standards. FDA inspectors documented multiple instances of analytical test results without original data, injections overwritten and deleted without justification, and chromatograms related to original test results overwritten by subsequent testing.
Additional violations related to laboratory records were found at the Piparia Silvassa drug manufacturing facility where the firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards.
FDA found during the inspection that the quality control laboratory was conducting trial injections of samples but failed to report all of the data generated. In addition, the laboratory controls failed to establish scientifically sound test procedures to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
Although quality control data confirmed microbial growth for Staphylococcus aureus in a medium that is intended to inhibit its growth, no investigation was initiated and the media batch was used, the warning letter noted.