British inspectors turned up a laundry list of apparent violations at two Indian manufacturers, leading them to block drugs from one of them and impose restrictions on the other’s GMP certificate.
In a report posted online April 4, the UK’s Medicines and Healthcare products Regulatory Agency warned that Rusan Pharma’s Gujarat manufacturing facility flunked a Jan. 22 inspection. The inspection of the formulation plant raised five system-wide issues that render the facility non-compliant. As a result, the MHRA’s report says that the production facility “should not be named on any marketing authorizations” while it remains non-compliant.
According to the report, the company does not appear to have corrected issues uncovered in an October 2010 inspection that revealed 40 GMP deficiencies, three of which were considered critical and six deemed major, many of them relating to record keeping.
The latest inspection concluded that the facility’s pharmaceutical quality system “was not operating in an adequate manner” to ensure consumer safety and that “there was not adequate evidence that the root causes of critical data integrity issues raised at the last inspection had been addressed.”
Specifically, the inspectors purportedly found “widespread failure” of the plant’s quality management system, including the core systems; electronic data controls and laboratory systems were not sufficient and unable to “assure data traceability or security;” contamination-control systems were deemed deficient and unable to properly assess the risk of cross contamination; critical controls over packaging regions in the plant were lax; and employee training was considered inadequate.
Marksans Pharma GMP Woes
MHRA also went after Marksans Pharma, issuing the Indian drugmaker a restricted GMP certificate following a Nov. 23 to 25, 2015 inspection of its Goa plant that revealed apparent quality systems deficiencies.
Inspectors paid the plant a visit last March and found a number of serious major deficiencies involving data integrity, management of corrective and preventative actions, change controls, product quality reviews and internal audits.
While November’s follow-up was intended to assess the company’s remediation plan, inspectors determined that there wasn’t enough evidence to demonstrate the effectiveness of the CAPAs taken. Further, the re-inspection supposedly identified a critical deficiency related to data integrity that involved mismanagement and poor oversight.
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