FDA seeks top-to-toe review of Wockhardt manufacturing
pharmafile | December 9, 2013 | News story | Manufacturing and Production |Â Â AZ, GMP, Taylor, Wockhardt. fdaÂ
Wockhardt has been asked to undertake an assessment of its entire manufacturing processes, according to an FDA warning letter.
Sent on 25 November but published last week, it provides further details of the current Good Manufacturing Practice (cGMP) violations that led to the FDA implementing a ban on imports from certain products made at Wockhardt’s Chikalthana facility. Earlier this year it also imposed a ban on products made at another plant in Waluj.
The violations were uncovered during a simultaneous inspection of both facilities in July and included inconsistencies in laboratory testing, with the deletion of data from some tests that the FDA inspector found were out-of-specification.
Other findings included poor documentation practices during in-process testing and a failure to investigate the failings. The agency said it was also unclear whether the problems were an isolated incident or indicative of widespread behaviour at the Chikalthana facility.
Earlier transgressions found at Wockhardt facilities included mould in raw material storage areas, a general lack of hygiene and urinals with inadequate drainage that allowed pools to accumulate on the floor.
“The lack of reliability and accuracy of data generated by your firm’s laboratory is a serious cGMP deficiency that raises concerns about the integrity of all data generated by your firm,” said the agency in the letter. “We are particularly concerned about your inability to implement a robust and sustainable quality system,” it added.
The agency goes on to say that Wockhardt’s management should undertake a “comprehensive and global assessment of your manufacturing operations to ensure that your systems and processes, and ultimately, the drug products you manufacture, conform to FDA requirements for safety, efficacy, and quality”.
The FDA says the company should hire a third-party auditor to assess its progress on the remediation plan, and also recommends that it interviews both present and past employees to get a clear picture of data reporting practices of recent years.
Analysts have suggested that the impact of the import ban could be significant for Wockhardt, as one of the products in the line of fire is its generic version of AstraZeneca’s Toprol XL (metoprolol) which is one of its biggest-selling products, with US sales currently running at around $120 million a year.
More than half of Wockhardt’s $1 billion annual turnover comes from the US market.
Phil Taylor
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