Control over production data still tripping up foreign drug manufacturers with FDA
- Over the past several years, the Food and Drug Administration has stepped up its oversight of foreign drug manufacturers, focusing particularly on suppliers located in India and China — two major markets for active pharmaceutical ingredients.
- With the posting of warning letters to the Chinese firm Jinan Janda Pharmaceutical Chemistry and Indian USV Ltd., the FDA's Center for Drug Evaluation and Research has cited 16 manufacturers so far in 2017, with 12 based in either China or India.
- Both Jinan Janda and USV were cited by FDA inspectors for failing to maintain appropriate controls over computer systems and laboratory records, problems that many foreign firms encounter.
The FDA inspected USV's facility in June 2016, finding that the company's systems allowed operators to delete testing files for instruments. Access to the microbial identification instrument, for example, was not restricted, and all users could delete or modify files.
Open access to instruments used to check product quality can potentially pose a problem for tracking down and investigating out-of-specification results or contamination — a key worry in a still developing supply chain.
USV had been flagged for similar violations at other facilities, leading the FDA to conclude the company's overall oversight and control of drug production to be inadequate.
At Jinan Janda, inspectors found staff had manipulated and deleted audit trails for many laboratory systems, such as gas chromatography and high performance liquid chromatography.
Jinan Janda told the FDA it would upgrade its systems to ensure compliance, but that didn't satisfy the agency.
"Procuring new instruments, installing new and upgraded data acquisition software, and enabling various software features are insufficient to achieve CGMP compliance," the FDA wrote in its warning letter. "These steps will be effective only if you implement appropriate procedures and systems to ensure that your quality unit reviews all production and control data and associated audit trails as part of the batch release process."
The steady drip of warning letters to manufacturers in India and China show the FDA isn't letting up in its efforts to oversee a secure supply chain of drug product. And the repeated problems with data integrity and investigations suggest such problems remain widespread.
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