Wockhardt revamps quality control team on FDA demand
20 March 2015
Wockhardt has put in place a new leadership team to supervise its quality assurance operations, egged on by US drug regulator Food and Drugs Administration (FDA), chairman Habil Khorakiwala said.
He said Wockhardt has been carrying on with quality updates on a regular basis since last year, as part of drug-maker's efforts to clear regulatory hurdles.
''Our entire quality team is new,'' Khorakiwala said, adding that none of the people who had handled quality operations in the past was at the helm, as that was what the US regulator wanted.
Wockhardt's Chikalthana and Waluj plants in Maharashtra are currently banned from selling their products in the US. Khorakiwala was speaking to the media on Thursday, following the latest inspection of its Chikalthana plant, Aurangabad, by the USFDA.
This was a follow-up of the inspection of Wockhardt's remedial measures late last year, he said.
On the fresh observations on the 483 form - where preliminary notes are recorded by the regulator - he clarified that it had to do with products manufactured before its GMP (good manufacturing practices) initiatives were implemented.
On Wednesday, Wockhardt told the stock exchange that its efforts at data control in laboratory and manufacturing were appreciated and there were no regulatory findings from the USFDA.
Khorakiwala further said that the company had created a global quality system with offices in India, the US and UK, besides training quality operations staff (whose numbers have been increased) and installing IT infrastructure.
The company's Kadaiya plant in Nani Daman continues in full compliance of the UK regulator's requirements, he said, referring to earlier troubles. Incidentally, the Chikalthana facility, which also faced some rough weather in the UK, has since been cleared.
Khorakiwala, however, did not give a timeline to resolving the compliance issue.