US FDA finds quality control, equipment issues at Alembic Pharma unit

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US FDA finds quality control, equipment issues at Alembic Pharma unit


MUMBAI: The US Food and Drug Administration, the drug regulator of the world’s largest drug market, found violations related to quality control, cleanliness and size of equipments, and inadequate sample collection procedures at Alembic Pharmaceuticals’ new sterile injectables unit in Karkhadi, Gujarat.

Earlier this month, the US drug regulator had issued a ‘Form 483’ to the facility of the drug company with five observations. A ‘Form 483’ is a document in which US FDA inspectors enlist the violations of good manufacturing practices observed by them during their inspection of a facility.

The US drug regulator said the quality control unit at Alembic Pharma’s Karkhadhi unit lacked “authority to fully investigate errors that have occurred”, a copy of the ‘Form 483’ accessed by ETMarkets.com showed.

The regulator said the company’s investigations into quality control in samples were inadequate as they did not address testing of toxins in a particular product batch.

The US FDA also raised issues with system for monitoring environmental conditions as it found the aseptic area at the facility to be deficient. “…failed to provide scientific justification demonstrating that samples collected for environmental monitoring represent the greatest risk of product contamination,” it said in the ‘Form 483’.

In another observation, the drug regulator noted that it found 15 recorded failures that were performed by the operator on a testing machine in one of the manufacturing lines in the facility, suggesting deficient procedures for operation of testing machines at the unit.

“Equipment used in the manufacturing, processing and packaging of drug products is not of appropriate design, size and suitably located to facilitate operations,” the FDA inspectors observed.

Alembic Pharma, in an exchange filing, had said that none of the observations made by the US FDA inspectors were related to data integrity and were “procedural in nature”.

The company has 15 working days to respond to the drug regulator with a corrective and preventive action plan, which if satisfactory, could pave the way for clearance of the facility by the US FDA.

The Karkhadhi unit is crucial for the company as it caters to the international markets such as the US and Europe, which are expected to be the growth drivers for the company.

On Wednesday, shares of Alembic Pharmaceuticals ended 0.3 per cent lower at Rs 957.60 on the National Stock Exchange.





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