Data-integrity concerns surface at Aurobindo Pharma’s India unit

By PharmaCompass

2019-06-13

Impressions: 129 Article

The US Food and Drug Administration (FDA) posted a Form 483 issued to Indian drugmaker Aurobindo Pharma after an inspection of the firm’s Unit 3 operations in Hyderabad last month. The 10-day inspection revealed data-integrity concerns as the FDA investigator observed “uncontrolled, loose, handwritten notebooks with what appears to be laboratory test data results”.

Additional data integrity concerns were also raised over electronic raw laboratory data. In many cases, samples were injected into chromatography equipment and were not run completely as per the method requirements.

The firm disregarded the data and labeled it as “incomplete data”, as it didn’t comply with the procedure that had to be followed. When the FDA dug deeper, it found multiple cases where such “incomplete data” was available for evaluation to determine whether the product was in specification or not.

In another case, when the FDA investigator reviewed electronic laboratory records of retained samples and compared them with the actual sample weights available, there was a significant mismatch of results.

The FDA investigator also witnessed an equipment cleaning operation that took significantly longer in the presence of the FDA official, as against all entries made in the logbook since the beginning of the year. During the cleaning, the FDA raised concerns over the methods being followed as some procedures were not documented and in another case operators claimed to have conducted a step which was actually not being undertaken.

As in the case of other inspections, the FDA also had issues with investigations and handling of customer complaints.

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