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US FDA questions data integrity in warning for Indian drugmaker

By Dan Stanton , 26-Feb-2014
Last updated on 26-Feb-2014 at 14:49 GMT

US FDA questions data integrity in warning for Indian drugmaker

Failing to ensure data integrity at a control laboratory in India has landed drugmaker USV with a US FDA warning letter.

The US Food and Drug Administration (FDA) inspected the site in Mumbai, India, last June and earlier this month sent USV – a maker of APIs, peptides, solid oral dose forms and biologics – a Warning Letter citing two specific violations of cGMP relating to data produced at the facility.

The firm failed to follow and document performance required laboratory control mechanisms, the FDA said in the letter, as well as failing to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records.

“The lack of reliability and accuracy of data generated by your firm is a serious CGMP deficiency that raises concern for all data generated by your firm,” the letter stated, citing as an example that sample weights used to calculate related compounds and impurities in drug applications were actually “backdated balance weight printouts produced after the analysis and generated for the notebooks.”

The agency also criticised the firm’s systems in the quality control (QC) laboratory with more than necessary personnel having access to high performance liquid chromatographs (HPLC) units and multiple users sharing computer logins.

Though USV had replied to the FDA, the agency noted the response “does not discuss how [it] will ensure that data audit trails will not be disrupted in the future and lacked a computer life cycle approach to, for example, assure routine verification of access controls in computer systems.”

GMP vigilance in India

Last summer, the FDA penalised fellow Indian drugmaker Posh Chemicals with a Warning Letter for failing to ensure data integrity and accused the firm of data falsification, whilst drugmaker Promed’s facility in Himachal Pradesh was also subject to a letter for a number of different GMP violations.

Furthermore, in the last few months Indian drugmakers Ranbaxy and Wockhardt have been subject to import alerts banning the supply of products into the US as the FDA push for a quality drive from oversea’s manufacturers.

Earlier this month, Commissioner Margaret Hamburg signed a statement of intent with the Indian authorities during a visit to the country. Since then, the FDA has begun recruiting to increase the number of inspectors in the country. 

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