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FDA Warns Japanese API Maker Over Data Integrity Issues

Posted 15 November 2016 | By Michael Mezher 

FDA Warns Japanese API Maker Over Data Integrity Issues

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Japanese active pharmaceutical ingredient (API) maker Sekisui Medical Co., Ltd. for a series of data integrity issues at the company's Iwate, Japan site.

Data Integrity

Data integrity issues have been a growing concern for regulators in recent years. In 2016, both FDA and the European Medicines Agency (EMA) released new draft guidance for industry detailing their expectations for data integrity.

So far, the vast majority of FDA warning letters for data integrity issues have been sent to companies in India and China.

Warning Letter

Over the course of a five-day inspection in June, FDA investigators say they observed several violations of current good manufacturing practice (cGMP) related to data integrity.

First, the investigators say the company "failed to maintain complete data from all laboratory analyses, and … relied on the incomplete information to determine whether [its] drugs met established specifications."

In one instance, the investigators say they found "numerous data files" in the recycling bin of the computer connected to two of the company's gas chromatography instruments.

"Specifically, our investigator found deleted data for residual solvent testing … in the recycling bin. Your records show that you retested the lot without documented justification or an investigation. You retained only the final test result," FDA writes.

In another instance, FDA said the company was unable to retrieve data from residual solvent release tests for two of its APIs. "Any data created as part of a cGMP record must be retained so that it can be evaluated by the quality unit as part of release criteria and maintained for cGMP purposes."

Additionally, the investigators say they found the company didn't have adequate controls to prevent employees from altering or deleting raw data in some of its systems. Furthermore, the investigators say such alterations or deletions weren't being captured by the system's audit trail.

"Your analyst demonstrated to our investigator that he could change the data, including injection time and date, without changes being captured in the audit trail, prior to printing the results," FDA says.

Analytical Methods

Aside from the data integrity issues, FDA investigators say that Sekisui did not adequately verify or validate the methods used to tests its API.

"You did not appropriately verify your tests methods for total aerobic microbial count and total combined yeasts and molds. Specifically, you did not show that these methods are capable of recovering microorganisms in the presence of the API," FDA writes.

Warning Letter

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