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Posted 22 April 2015 | By Alexander Gaffney, RAC,
The US Food and Drug Administration (FDA) has sent a Warning Letter to a Chinese active pharmaceutical ingredient (API) manufacturer after finding that the firm did not exercise proper control over its manufacturing data.
The Warning Letter, sent to Yunnan Province-based Yunnan Hande Bio-Tech, is the latest in a long string of warnings from FDA related to data integrity concerns. As detailed by Regulatory Focus, more than a dozen Indian drug manufacturers have been warned by FDA since 2013 for data integrity-related deficiencies. Several other Chinese manufacturers have also been warned in recent years.
FDA's concern, as explained in its various Warning Letters, is that if it can't trust the accuracy of the data provided by a manufacturer, it is unable to determine if its products are safe, effective or manufactured according to federal quality standards. A company might, for example, discard or delete data indicating that some of its products failed pre-specified standards, thereby making it seem as though its manufacturing processes were far more precise than they actually were. This violates FDA's longstanding credo that quality must be designed into the manufacturing process—not tested for at the end of the manufacturing process.
FDA's latest Warning Letter is familiar reading relative to its other data integrity letters.
Regulators allege that during its inspections of Yunnan Hande Bio-tech's facilities in April 2014, it determined that the company "lacked controls to prevent the unauthorized manipulation" of laboratory data. A computer hooked up to the company's infrared spectrometer did not have any way to prevent the "deletion or alteration of raw data," FDA said in its letter. The software also lacked any audit trail functions which would allow the company or FDA to determine which changes had been made, when and by whom.
In another case, FDA contended that an analyst employed by the firm "altered the identity test results" for a lot of API, which resulted in the drug ingredients being approved and released. "This practice is unacceptable and raises serious concerns regarding the integrity and reliability of the laboratory analyses conducted by your firm," FDA wrote in its letter.
"Your quality unit failed to detect that your laboratory altered IR raw data and misrepresented the results for approval and release," FDA added.
The alleged deficiencies were characterized by FDA as "serious," and the agency recommended the company undertake a comprehensive evaluation of its quality systems and existing data to determine if any other inaccuracies took place.
FDA Warning Letter
Tags: Warning Letter, Data Integrity
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