Inspection at India’s Ipca Labs Reveals Systemic Data Manipulation
The FDA has slammed yet another Indian drugmaker for data integrity issues: This time it rebuked Ipca Laboratories for data falsification at three of the company’s manufacturing facilities.
During a July 2014 inspection at the company’s Ratlam API facility in Madhya Pradesh, inspectors determined that someone had deleted original data for test samples and back dated test data. In addition, computerized systems lacked sufficient controls to prevent unauthorized access or changes to data.
“These practices appear to be commonplace in your analytical laboratory,” the warning letter chides, adding that during the inspection an analyst told inspectors, “’if we find a failure, we set back the date/time setting and re-integrate to achieve passing results.’” The analyst noted that “deleting, overwriting, changing integration parameters, and altering PC date and time settings were done for raw materials, in-process testing and finished API drugs.”
The warning letter references an anonymous email dated Aug. 5, 2013, notifying quality management about data falsification and manipulation in the laboratory and cited the company for failing to do anything about it.
Multiple Plant Failures
The agency uncovered similar deviations at the company’s finished products manufacturing plants at Pithampur and Piparia Silvassa. During an October 2014 inspection at the Pithampur facility, investigators found multiple instances of trial injections of samples in which original test results were missing with no explanations or justifications given.
“Because your quality unit did not review the original electronic data, you were unable to detect rewritten, deleted or overwritten files,” the warning letter says. “Without this information, you have no way to ensure that the tests you use to evaluate the quality of incoming raw materials are accurate or reliable.”
Last March, the FDA halted imports of drugs from Ipca’s Pithampur and Piparia Silvassa manufacturing facilities due to GMP violations.
Months earlier, the agency barred shipments of antibiotics and other finished drugs produced at Ipca’s Ratlam facility.
During a December 2014 inspection at the Piparia Silvassa facility, investigators uncovered equipment that was contaminated by Staphylococcus aureus and E. coli, and although QC data confirmed microbial growth, the media batch still was used for samples. The warning letter notes that the company’s response lacked an evaluation of the adequacy of lab controls and a determination of whether personnel — including supervisors — were “appropriately qualified” to detect and correct deviations.
Global CAPA Needed
The agency requested a copy of the company’s investigations of the quality lapses at all three facilities, as well as root cause determinations and corrective and preventive actions. The agency requested a risk assessment of how the deficiencies affect the reliability and completeness of quality information, and a management strategy that includes a detailed global corrective action and preventive action plan.
The company did not respond to a request for comment. In its annual report to investors, Ipca referenced the FDA inspections, noting that 2014-15 was a “challenging year for the company,” and that the three plants received import alerts as a result of the issuance of Form 483s.
The company said it was implementing “comprehensive remedial measures” at all of its manufacturing sites, including a review of all processes and procedures, overhaul of training systems, recruitment of senior quality personnel and automation of quality control labs, the report says.
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