 "US drug regulator wants third party assessment on extent of inaccuracies")
Dr Reddy's management has already announced that they were considering third party evaluation of manufacturing facilities, either limited to those cited in the warning letter or across all the plants. The company had said as a matter of policy any new measures initiated on improving quality control systems or manufacturing standards at one facility would be implemented across all of its manufacturing sites.
The drug regulator said the third party assessment should include the extent of inaccuracies in recorded and reported data, risk assessment of the potential effects of observed failure on the quality of drug products and a management strategy pertaining to a global corrective action and preventive action plan.
In the letter, which is now available on its website, the US FDA had raised concerns over the failures perceived by the inspectors in a variety of situations involving the quality control protocols across the three manufacturing facilities of Indian generics drug major.
Dr Reddy's scrip had corrected by over 20 per cent during this month after the company acknowledged the receipt of a warning letter from the US drug regulator on November 6.
Meanwhile, the regulator has also pointed out at the presence of a previously existed testing lab in one of these facilities for not being found a mention in the records.
During the inspection of Srikakulam Active Pharmaceutical Ingredients(API) plant between November 17-21, 2014, the presence of an uncontrolled 'Custom QC Laboratory(CQC)' was discovered by its inspection team, according to the letter.
"The existence of this laboratory was previously unknown to FDA. Your QC associate director acknowledged that the CQC laboratory was involved in CGMP analysis of APIs intended for export to the United States through 2012," the letter said.
The company spokesperson did not respond to a query about the reference to this previously existed testing lab.
The regulator has listed out a set of critical observations about the electronic testing records generated by this laboratory way back in 2012. It said the company has not assessed how its reliance on the ' incomplete and inaccurate data' generated by the CQC laboratory, which was operational until April, 2012. may have affected the quality of the APIs.
The letter has given unit-wise observations on the two other units, namely CTO unit 5 or the API facility at Miryalaguda in Telangana and the unit-7 Oncology formulations plant located at Duvvada VSEZ in Visakhapatnam in Andhra Pradesh.
It has cited how instances of manual interventions at a vials assembly in Duvvada facility risks compromising the sterility of the product and termed it as a deviation from the approved standard operating procedure (SOP). In conclusion the letter stated that several violations were recurrent or represent long-standing failures to adequately resolve significant manufacturing quality problems.
The company earlier stated that it has already initiated corrective actions in these facilities and it would work with the US FDA on achieving compliance on issues raised by the regulator.
