Data Integrity and Recordkeeping Problems Prompt FDA Warning to Indian API Maker
The FDA has slapped another Indian active pharmaceutical ingredient maker with a warning for data integrity weaknesses, including printing batch records from personal computers over which the company lacked adequate controls.
The batch record problem was one of several violations that the FDA cited in its warning letter to Sharp Global Limited that focused on the company’s failure to implement proper controls to ensure key quality data wasn’t manipulated or deleted. This is the 11th warning letter that the agency has issued in 2014 to manufacturers, primarily in India, that cite data integrity practices.
Sharp responded that it had changed its standard operating procedure for record controls in response to the findings. The company, however, failed to present evidence that all operators were trained on the revised SOP, according to the letter that resulted from a March inspection of the firm’s New Delhi, India, facility.
The FDA also found that the company’s gas chromatographs didn’t prevent the deletion or altering of raw data files, and lacked audit trails that record any changes to data, according to its Oct. 15 letter.
Sharp management told investigators that the company’s practice was to delete raw data files once the chromatograms were printed. Such records, however, are critical to support release testing, according to the FDA, which increasingly is looking for data integrity problems at sites, noting that one failure could cast doubt on all data generated by a facility.
In addition, the inspection found batch records related to non-U.S. products that weren’t completed or properly signed by quality control officials.
Furthermore, Sharp didn’t fully register all of its New Delhi facilities this year before trying to import products into the U.S., the agency found.
If Sharp doesn’t address the violations, the FDA said it could withhold approval of applications and supplements that cite the API maker as a supplier. The agency also threatened to slap an import alert on Sharp.
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