Data integrity concerns at Dr Reddy's; problems of sterility assurance at Aurobindo

Data integrity concerns at Dr Reddy’s; problems of sterility assurance at Aurobindo

By PharmaCompass

2019-02-28

Impressions: 107 Article

Indian drug majors continue to be in news for regulatory non-compliance. Last week, we reported on FDA issuing a Form 483 to Dr Reddy’s finished formulation plant in Bachupally, Hyderabad, after its inspection. Last month, the Indian drugmaker’s FTO-SEZ Unit I facility in Srikakulam was inspected (from January 7 to 15, 2019) and failure to properly investigate batch failures was cited as a concern once again.

In a batch of tablets which failed because of higher impurities, the FDA investigators found that during process validation “no studies were conducted to evaluate uniformity of any impurities in the finished dosage”.

Data integrity concerns also re-emerged as analytical equipment used for in-process testing of tablets was found to use common passwords and operators had the ability to change the time and date of the equipment.

Audit trails review procedures, which are used to determine the level of data sanctity in an organization, were found to be deficient. In one case, an audit trail for a particle size analyzer showed 19 records were created while the electronic data showed only one entry.

Aurobindo Pharma was another Indian drug maker in news for regulatory non-compliance. Last year, Aurobindo had pledged to resolve issues at a sterile manufacturing plant in India after an FDA inspection cited it for problems that could lead to contamination. Seems like it didn’t do enough. FDA inspectors visited the key Aurobindo facility recently and found the same shortcomings.

The agency posted a Form 483 for the Unit IV facility in Pashamylaram, Hyderabad. It was issued post an inspection from December 3 to 14, 2018.

This was the second inspection of the facility carried out last year, the first one being in March. The plant is important to Aurobindo’s US business. The company has projected it will generate about US$ 250 million in sales from that facility by the end of 2020.

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