Drug Manufacturer Lacked Adequate Controls Over Manufacturing, FDA Warns

Regulatory NewsRegulatory News | 11 March 2015 |  By 

A Thailand-based active pharmaceutical ingredient (API) manufacturer has been warned by the US Food and Drug Administration (FDA) for failing to ensure that its manufacturing data could not be altered or falsified—claims similar to those levied against many Indian pharmaceutical companies.

In a 27 February 2015 Warning Letter to Novacyl Ltd, FDA references an April 2014 inspection of the company's Samukprakam, Thailand manufacturing facility. There, FDA said it "identified significant deviations from current good manufacturing practice (CGMP)," the regulations enforced by FDA to ensure that products are produced under the proper manufacturing conditions.

Some of the problems cited by regulators should be familiar to readers of recent Warning Letters targeted to other Asian manufacturers.

For example, Novacyl is accused of having "inadequate controls over access" to its data. For regulators, those lapses can be extremely concerning. They could, for example, allow an employee to change the results of tests on materials which did not pass quality or identity checks by the company, or even make up results for tests which never occurred.

Selective Edits

In one case, Novacyl was accused of "selectively" invalidating a test on one of its drug products, raising FDA concerns.

"The inadequate controls over access to your data raise questions about the authenticity and reliability of your data and the quality of the APIs you produce," the regulator wrote. FDA said the company "did not have proper controls in place to prevent the unauthorized manipulation of your laboratory’s raw electronic data," and also lacked "active audit trail functions" meant to record who changed records, and when. The company's gas chromatograph software also reportedly lacked password protection, meaning any employee could alter data.

The Warning Letter is at least the second for Novacyl, which in December 2014 also received a warning citing similar alleged infractions at its Jiangsu, China manufacturing facility. FDA said the repeated problems raise concerns that the company's "global quality system does not adequately ensure the accuracy and integrity of the data generated at your facilities to support the safety, effectiveness and quality of the drugs [Novacyl] manufactures."

Novacyl is not currently subject to any import alerts, though FDA said its products could be subject to restrictions until the company is found to be in compliance with FDA manufacturing regulations.


FDA Warning Letter


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